Cosmetics Labeling Guide - FDA
Cosmetics Labeling Guide - FDA
The Cosmetics Labeling Guide provides step-by-step help with cosmetic labeling, with examples
and answers to questions manufacturers often ask about labeling requirements under U.S. laws
and related regulations.
On this page:
Type Size
Identity Labeling
Warning Statements
Ingredient Labeling
Prominence
Ingredient Identification
Order of Declaration
Fragrances and Flavors
Drug Ingredients
Color Additives Added for Color Matching
Incidental Ingredients
Dissimilar Product Assortments
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21 U.S.C. 321-392
The cosmetics marketed in the United States, whether they are manufactured here or are
imported from abroad, must comply with the labeling requirements of the Federal Food, Drug,
and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act, and the regulations
published by the Food and Drug Administration under the Authority of these two laws.
The FD&C Act was enacted by Congress to protect consumers from unsafe or deceptively labeled
or packaged products by prohibiting the movement in interstate commerce of adulterated or
misbranded food, drug devices and cosmetics.
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To ensure that packages and their labels provide consumers with accurate
information about the quantity of contents and facilitate value comparisons.
15 U.S.C. 1451-1460
The FP&L Act was passed by Congress to ensure that packages and their labels provide
consumers with accurate information about the quantity of contents and facilitate value
comparisons.
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The FD&C Act prohibits the marketing of cosmetics that are adulterated or
misbranded as well as their adulteration or misbranding while in interstate
commerce.
The FD&C Act prohibits the marketing of cosmetics that are adulterated or misbranded as well
as their adulteration or misbranding while in interstate commerce.
Sec. 602 of the FD&C Act defines the conditions which cause a cosmetic to be deemed
misbranded.
Labeling may be considered misleading not only because a label statement is deceptive but also
because a material fact is not revealed on a label.
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A fact may be material in light of a statement made on a label or because certain consequences
may result from the recommended use of a product.
What is a cosmetic?
A cosmetic is a product, except soap, intended to be applied to the human body for
cleansing, beautifying, promoting attractiveness, or altering the appearance.
As defined in section 201(i) of the FD&C Act, a cosmetic is a product, except soap, intended to be
applied to the human body for cleansing, beautifying, promoting attractiveness or altering the
appearance.
In short, one may say that a cosmetic is a product intended to exert a physical, and not a
physiological, effect on the human body.
The raw materials used as ingredients of cosmetic products are by law also cosmetics.
In section 701.20 of Title 21 of the Code of Federal Regulations [21 CFR 701.20], the Food and
Drug Administration (FDA) defines the term "soap" as a product in which the non-volatile
portion consists principally of an alkali salt of fatty acids, i.e., the traditional composition of
soap; the product is labeled as soap; and the label statements refer only to cleansing. If cosmetic
claims, e.g., moisturizing, deodorizing, skin softening etc., are made on a label, the product is a
cosmetic. Synthetic detergent bars are also considered cosmetics, although they may be labeled
as "soap."
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"Intended use" within the meaning of the FD&C Act is determined from its label or
labeling.
According to Senate Report No. 493 and court decisions, the term "intended" in the legal
definition of the term "cosmetic" or in other definitions means, with respect to the use of a
product, its directed or prescribed use as determined from the statements made on a product's
label or labeling.
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The courts, in deciding whether a product is a "cosmetic", a "drug", or both a "drug" and a
"cosmetic", have relied principally on the consumer's perception of the meaning of a label
statement and less so on the interpretation of the meaning of a label statement by the labeler or
a regulatory agency.
Section 509 of the FD&C Act provides that the categories of "drug" and "cosmetic" are not
mutually exclusive.
A product customarily distributed for retail sale for use by consumers or for the
performance of services at home and usually consumed during such use.
Section 509 of the FD&C Act provides that the categories of "drug" and "cosmetic" are not
mutually exclusive.
Package
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The term package is defined in the Fair Packaging and Labeling Act [sec. 10(b)] and the Code of
Federal Regulations [21 CFR 1.20].
Essentially, the "package" is the outer container of a product as, for example, a box or folding
carton. However, the "package" can also be the immediate container, e.g., bottle, jar or aerosol
can that holds the product if the immediate container is not displayed in a box or folding carton.
Label
The term "label" is defined in the FD&C Act and the FP&L Act. The definitions differ in that
under the FD&C Act definition a label is "a display of written, printed or graphic matter upon the
immediate container," and under the FP&L Act definition "written, printed or graphic matter
affixed to any consumer commodity or affixed to or appearing upon a package containing any
consumer commodity."
One may say that the term "label" applies in the first instance to the information appearing
directly on the immediate container and in the second instance to information attached to the
immediate container and directly on or attached to the outer container if so packaged.
The FD&C Act, however, requires in sec 201(k) that any information required to appear on the
label of the immediate container shall also appear on the outside container of the retail package
or is legible through the outside container.
Labeling
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The FD&C Act defines in sec. 201(m) "labeling" to mean "all labels and other written, printed or
graphic matter on or accompanying such article."
This includes labels, inserts, risers, display packs, leaflets, promotional literature or any other
written or printed information distributed with a product.
The part of a label that the consumer sees or examines when displayed for retail
sale
A label may consist of more than one panel. It may consist of a front panel, side panels and a
back panel. Back and side panels are generally called information panels.
The FP&L Act also defines for consumer commodities, or packages containing a consumer
commodity, the term "principal display panel," otherwise known for short as PDP.
The "principal display panel" is that part of a panel that is most likely to be shown or examined
under customary conditions of display for retail sale. Usually, it is the front panel of the label of
the outer package.
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Location
Size
Multiple PDPs
Exceptions
Decorative containers
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Compacts or pencils
Containers of 1/4 av. oz. or 1/8 fl. oz. capacity
Display cards
As mentioned before, the PDP is that part of the label that is most likely to be shown or
examined under customary conditions for retail sale.
Regulations [21 CFR 701.10] published by the FDA require that the PDP be large enough to
accommodate all required label information with clarity and conspicuousness.
If a package bears more than one PDP, the information required to be placed on the PDP must
be duplicated on all PDPs.
For the purpose of assuring uniform type size for declaring a product's net quantity of contents,
the size of the surface area bearing the PDP, and not the size of the PDP itself, is the determining
factor. The area of the PDP is for a:
Any other shape of container: 40% of total container surface, excluding top, bottom, neck,
shoulder, flanges.
The PDP of a "boudoir-type" or decorative cosmetic container, e.g., cartridge, pill box, compact
or special variety, and those containing 1/4 oz or less may be a tear-away tag or tape affixed to
the container [21 CFR 701.13(e)(1)]. It may also be the display panel of a card to which the
immediate container is affixed [21 CFR 701.13(e)(2)].
Outer Container
(Or Label of Single Container Product)
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Information Panels:
The information above must appear on the label of the outer container which usually is a box,
folding carton, wrapper etc. holding the inner (immediate) container. The immediate container
holding the cosmetic product also is the outer container if it is not displayed in a box, folding
carton etc.
Please note that only the label of an outer container has a PDP.
Statement of the brand name of the product is not a regulatory requirement under the FD&C or
FP&L Act.
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Warnings
The information above must appear on the label of the inner (immediate) container holding the
cosmetic product. The inner container is packaged and displayed in a non-transparent box,
folding carton etc. If the outer container is removed and the product displayed for sale without
it, the label of the immediate container becomes a label of an outer container.
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Section 602(c) of the FD&C deems a cosmetic misbranded if any word, statement, or other label
or labeling information required by law or regulation is not placed on the label or labeling with
such prominence and conspicuousness that it is likely to be read, or if it is not stated in such
terms that it is likely to be understood by ordinary individuals.
Panel size
Background contrast
21 CFR 701.2
Regulations [21 CFR 701.2] published by the FDA offer detailed information on how to comply
with the requirement for prominent and conspicuous placement of information on cosmetic
labels or labeling.
Panel display: The required information must be on a panel which is presented or displayed
under customary conditions of purchase. This eliminates placement of required information on
a bottom panel of a cosmetic unless it is very small and customarily picked up by hand where
inspected for possible purchase.
Panel Size: The label must be large enough to provide sufficient space for prominent display of
the required information.
Style and Size of Letters: The type must be of such size, and at least of the required
minimum size, and of such style that the required label statements are easily readable.
Background Contrast: The contrast must be sufficient to make the required label statements
conspicuous and easily readable.
Obscuring Designs, Vignettes: The required statements must not be obscured by vignettes
or other designs or by crowding with other printed or graphic matter.
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Language
21 CFR 701.2(b)
English Language Statements: All label or labeling statements required by law or regulation
must be in the English language. Products distributed solely in Puerto Rico or a Territory where
the predominant language is one other than English, may state the required label information in
the predominant language in place of English.
Foreign Language Statements: If the label contains any foreign language representation, all
statements required by regulation must also appear on the label in the foreign language. If
labeling bears foreign language representations, the required statements must appear on the
label or other labeling as required in English.
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Type Size
Net Contents:
Ingredient Declaration: Generally, in letters not less than 1/16" in height [21 CFR 701.3(b)].
If surface area available to bear label (excludes surfaces with decorative relief, sculptured
surfaces) is less than 12 square inches, letter height may be not less than 1/32" [21 CFR
701.3(p)].
Net Contents Declaration on PDP: Minimum letter height determined by the area of the
PDP. In the case of "boudoir-type" containers, including decorative cosmetic containers of the
cartridge, pill box, compact or pencil type, and cosmetics of 1/4 oz. or less capacity, the type size
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is determined by the total dimensions of the container. If the container is mounted on a display
card, the display panel determines the letter height [21 CFR 701.13(e) and (i)].
Warning Statements: Type size no less than 1/16" unless smaller size established by
regulation [21 CFR 740.2].
Letter Height: The lower case letter "o" or equivalent when upper and lower case letters are
used [21 CFR 701.13(h)].
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Identity Labeling
Descriptive name
Fanciful name
Illustration
Prominence
Placement
Sec. 4 of the FP&L Act [21 U.S.C. 14554] requires that a consumer commodity bear a statement
of identity. Regulations [21 CFR 701.11] published by the FDA require that the identity statement
appear on the PDP.
The identity of the commodity may be expressed in terms of the common or usual name of the
cosmetic, a descriptive name, or when the nature of the cosmetic is obvious, a fanciful name. It
may also be expressed in form of an illustration.
The identity statement must be in bold type and in a size reasonably related to the most
prominent printed matter, which is usually the name of the cosmetic. It must be in lines
generally parallel to the base on which the product rests when displayed at retail.
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Corporate name
Manufactured for...
Distributed by...
Address
Principal place of business
21 CFR 701.12
The name and business address appearing on the label may be those of the manufacturer, packer
or distributor.
If the name and address is not that of the manufacturer, the name must be preceded by phrases
such as "Manufactured for ...", "Distributed by ...", or other appropriate wording.
The name of the firm must be the corporate name, and the address may be that of the principal
place of business. Stating also the name of a corporation's particular division is optional.
The business address must include the street address, name of the city and state, and the ZIP
code. The street address may be omitted if the firm is listed in a current city or telephone
directory.
The Tariff Act of 1930 requires that imported products state on the label the English Name of the
country of origin.
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Quantity of Contents
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Location: If the cosmetic is sold at retail in an outer container, the net contents statement must
appear (1) within the bottom 30% of the PDP of the outer container, generally parallel in line to
the base on which the package rests, and (2) on an information panel of the inner container. The
bottom location requirement is waived for PDPs of 5 square inches or less.
The PDP may be a tear-away tag or tape affixed to a decorative container or to a container of less
than 1/4 oz., or it may be the panel of a display card to which the container is affixed.
Prominence: The declaration must be a distinct item, separated from other printed matter by
a space equal to at least the height of the lettering used in the declaration and twice the width of
the letter "N".
Conspicuousness: The print must be easily legible bold face type in distinct contract to
background and other matter on the package. The letter height must be at least that of the lower
case letter "o", and the aspect ratio of height to width must not exceed 3:1.
The type size, as determined by the area of the PDP must be at least 1/16 in. if PDP area 5 sq.
in., 1/8 in. if PDP area > 5 to 25 sq. In., 3/16 in. if PDP area > 25 to 100 sq. in., and 1/4 in. if PDP
area > 100 sq. in.
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On display card
In outer container
21 CFR 1.24
Cosmetics in packages containing less than 1/4 av. oz. or 1/8 fl. oz. are exempt from the net
quantity of contents declaration if affixed to a properly labeled display card or sold at retail in a
properly labeled outer container [21 CFR 1.24].
When a cosmetic is required to bear net quantity of contents declarations on the inner and outer
container, the declaration on the outer container must appear on the PDP; on the inner
container, it may appear on an information panel other than the panel bearing the name of the
product, i.e., the front panel.
Quantity of Contents
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Accuracy: The net quantity of contents (net contents) declaration must accurately reveal the
quantity of cosmetic in the container in terms of weight, volume, measure, numerical count, or
combinations of count and weight, volume or measure. Reasonable variations due to loss or gain
of moisture, or deviations in good manufacturing practice, are acceptable. In case of an aerosol
product, the net contents statement must express the net quantity of contents expelled.
Product Consistency: Unless there is a firmly established, general consumer usage or trade
custom to the contrary, the statement must be in terms of fluid measure if the cosmetic is liquid
and in terms of weight if the cosmetic is solid, semi-solid, viscous, or a mixture of solid and
liquid. Fluid measures must express the volume at 68°F (20°C). The customary net contents
declaration for aerosol products is in terms of weight.
Systems: Weight is expressed in terms of avoirdupois pound and ounce. Fluid measures are
expressed in terms of the U.S. gallon, quart, pint and fluid ounce. Net contents may additionally
be stated also in the metric system.
Unit Terms: The term "net weight" or "net wt." must be used in conjunction with a weight
statement, and the term "net contents," "net" or nothing must be used in connection with a
liquid statement.
Additional abbreviations are for: weight - wt., fluid - fl., gallon - gal., quart - qt., pint - pt., ounce
- oz., pound - lb.
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In case of a weight ounce statement, the term "oz." is sufficient. A fluid ounce is expressed as "fl.
oz."
Examples:
Dual Declaration: If the net weight exceeds one pound but is less than 4 pounds, the net
contents statement must reveal the total number of ounces followed, in parenthesis, by the
number of pounds and ounces or by the number of pounds and fraction thereof. Fluid measures
exceeding one pint, but being less than one gallon, must be expressed in terms of the total
number of fluid ounces followed, in parenthesis, by the number of quarts, pints and ounces or by
the fractions of the quart or pint.
Examples:
Declaration of fractions: Fractions may be expressed in terms of common fractions ranging from
1/2 to 1/32 or as decimal fractions of no more than two significant numbers.
Quantity of Contents
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On Information Panel
Economy Size: Representations of this type are permitted if the firm offers at least one other
packaged size of the same brand, only one is labeled "economy size," and the unit price of the
package so labeled is substantially (at least 5%) reduced compared to that of the other package.
Giant Pint, Full Quart: Supplemental statements describing the net quantity of contents are
permitted on panels other than the PDP. However, these statements must not be deceptive or
exaggerate the amount present in the package.
Cosmetic Kit: If a package contains the integral components making up a kit and delivers the
components in the manner of an application as, for example, a home permanent wave kit, the
net contents declaration may be stated in terms of the number of applications as per given
instructions [21 CFR 701.13 (g) (2)].
General Requirement:
Prominence
Placement
Spacing
Conspicuousness
Contrast
Type size
Regulations require that "[the label of a cosmetic product shall bear a warning statement
whenever necessary or appropriate to prevent a health hazard that may be associated with the
product" [21 CFR 740(1)]. A cosmetic not bearing a necessary warning statement may be
considered misbranded under sec. 602(a) of the FD&C Act because it fails to reveal a fact
"material ... with respect to consequences which may result from the use of the article" [sec
201(n), FD&C Act].
Prominence: A warning statement must appear on the label prominently and conspicuously as
compared to other words, statements or designs so that it is likely to be read by ordinary
consumers at the time of purchase and use.
Conspicuousness: The lettering must be in bold type on contrasting background and may in
no case be less than 1/16 inch in height.
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21 CFR 740.10
A cosmetic is considered misbranded if its safety has not adequately been substantiated, and it
does not bear the following conspicuous statement on the PDP:
a. Reliance on available toxicological test data on its ingredients and on similar products, and
b. Performance of additional toxicological and other testing appropriate in the light of the
existing data.
Even if the safety of each ingredient has been substantiated, there usually still is at least some
toxicological testing needed with the formulated product to assure adequate safety
substantiation.
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Cosmetic Aerosols
The words "Avoid spraying in eyes" may be omitted if the product is not expelled as a spray.
Example: Aerosol shave cream.
The word "puncture" may be replaced by the word "break" if the product is packaged in a glass
container.
If the product is intended for use by children, the phrase "except under adult supervision" may
be added at the end of the last sentence of the warning.
Cosmetic Aerosols
2.Products which do not expel the propellant at the time of use. Examples: products with built-
in piston barrier or propellant bag.
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Caution--For external use only. Spray at least 8 inches from skin. Do not apply to
broken, irritated, or itching skin. Persistent, unusual odor or discharge may
indicate conditions for which a physician should be consulted. Discontinue use
immediately if rash, irritation, or discomfort develops.
21 CFR 740.12
A feminine deodorant spray which, for the purpose of this regulation, is defined as "any spray
deodorant product whose labeling represents or suggests that the product is for use in the
female genital area or for use all over the body" must bear the caution stated below.
If the expelled product does not contain a liquefied halocarbon or hydrocarbon propellant, the
sentence "Spray at least 8 inches from skin" may be omitted.
The regulation further states that the use of the word "hygiene" or "hygienic" or similar words
renders any such product misbranded.
21 CFR 740.17
A foaming detergent bath product--also known as bubble bath product--is, for the purpose of
this regulation, defined as "any product intended to be added to a bath for the purpose of
producing foam that contains a surface-active agent serving as a detergent or foaming
ingredient."
The caution stated above is required on the label of any foaming detergent bath product which is
not clearly labeled as intended for use exclusively by adults. The following are two examples of
label statements identifying a product as intended for use exclusively by adults: "Keep out of
reach of children" and "For adult use only."
If the bubble bath product is intended for use by children, the phrase "Keep out of reach of
children" may be expanded to further read "except under adult supervision."
The regulation further requires that the label "Shall bear adequate directions for safe use" of the
product.
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21 CFR 701.3
Cosmetic ingredient labeling became an issue in the early 1970s. Guidelines for ingredient
labeling were published in mid-1972. Regulations were proposed in early 1973. After publication
of two final regulations, stays of final regulations, terminations of stays, and lengthy court
proceedings challenging the legality of the published regulations, the requirement for cosmetic
ingredient labeling became fully effective in early 1977.
The regulations requiring the declaration of cosmetic ingredients were published under the
authority of the FP&L Act [secs. 5(c) and 6(a); 15 U.S.C. 1454 and 1455] and FD&C Act [sec.
701(e); 21 U.S.C. 371(e)].
Since the FP&L Act applies only to consumer commodities and their packages as defined in the
Act, cosmetic ingredient declarations are required only on the label of the outer container of
cosmetics customarily sold at retail or used in the performance of services conducted within the
households. It does not apply, for example, to products used at professional establishments or
samples distributed free of charge, unless such products are customarily also sold at retail, even
if they were labeled "For professional use only."
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Exception: 1/32 inch
If total available labeling surface area is less than 12 sq. in.
Information panel
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The ingredient declaration may appear on any information panel of the package which is the
outer container in form of a folding carton, box, wrapper etc. if the immediate container is so
packaged, or which is the jar, bottle, box etc. if the immediate container is not packaged in an
outer container. It may also appear on a tag, tape or card firmly affixed to a decorative or small
size container.
Prominence: The declaration must appear with prominence and conspicuousness so that it is
likely to be read and understood (read with ease) by ordinary individuals under normal
conditions of purchase. The letters must not be obscured by design, vignettes, background or
crowding.
Type Size: Not less than 1/16 inch in height. It may be not less than 1/32 inch in height if the
total surface area available to bear labeling (which excludes bottom, shoulder, neck, flange,
decorative or sculptured surfaces) is less than 12 square inches.
The type size consisting of upper and lower case letters is determined by the height of the lower
case letter "o".
The ingredient declaration may appear on any information panel of the package which is the
outer container in form of a folding carton, box, wrapper etc. if the immediate container is so
packaged, or which is the jar, bottle, box etc. if the immediate container is not packaged in an
outer container. It may also appear on a tag, tape or card firmly affixed to a decorative or small
size container.
Prominence: The declaration must appear with prominence and conspicuousness so that it is
likely to be read and understood (read with ease) by ordinary individuals under normal
conditions of purchase. The letters must not be obscured by design, vignettes, background or
crowding.
Type Size: Not less than 1/16 inch in height. It may be not less than 1/32 inch in height if the
total surface area available to bear labeling (which excludes bottom, shoulder, neck, flange,
decorative or sculptured surfaces) is less than 12 square inches.
The type size consisting of upper and lower case letters is determined by the height of the lower
case letter "o".
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21 CFR 701.3(c)
Section 701.3(c) requires that an ingredient be identified by the name established by the
Commissioner for the purpose of cosmetic ingredient labeling or, in the absence of a name
established by the Commissioner, the name adopted for that ingredient in the editions and
supplements of the compendia listed below.
The Commissioner may establish a name as petitioned or propose such a name on his own
initiative. See section 701.3(e). The names specified by the Commissioner are listed in section
701.30.
The currently recognized edition of the CTFA (Cosmetic, Toiletry and Fragrance Association,
Inc.) Cosmetic Ingredient Dictionary is the second edition published in 1977. This edition is
recognized only in part, i.e., not all names listed in the second edition have been adopted.
The third edition of the CTFA Cosmetic Ingredient Dictionary published in 1982 and the
Supplement published in 1985 have not yet been recognized. However, FDA has informed the
CTFA that the agency will not take regulatory action against products labeled in accordance with
these editions while their review is in progress.
The compendia are listed in the descending order by which they must be utilized for
identification of an ingredient name. If none lists a name for an ingredient, the name generally
recognized by consumers, or the chemical or technical name or description, must be used.
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Exceptions...
Active drug ingredients
Ingredients with less than 1% concentration
Color additives
"And other ingredients"
The ingredients must be listed in descending order of predominance. However, there are a few
exceptions to this requirement.
1. If the cosmetic is also a drug, section 502(c) of the FD&C Act requires that the active drug
ingredient(s) be declared before declaration of the cosmetic ingredients. A declaration, thus,
would read as follows: "Active Ingredient: ... (Name of drug ingredient). Other (or Cosmetic)
Ingredients: ... (Names of cosmetic ingredients in descending order)." [§ 701.3(d)]
2. Ingredients present at a concentration not exceeding 1% may be listed in any order after the
listing of the ingredients present at more than 1% in descending order of predominance.
[§ 701.3(f)(2)]
3. Color additives of any concentration may be listed in any order after the listing of the
ingredients which are not color additives [§ 701.3(f)(3)].
4. The name of an ingredient accepted by FDA in accordance with the procedure established in
§ 720.8 as a trade secret need not be disclosed on the label. In lieu of declaring the name of that
ingredient, the phrase "and other ingredients" may be used at the end of the ingredient
declaration [§ 701.3(a)].
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Order of Predominance
Lipstick
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In this example, the correct ingredient declaration lists castor oil (58), lanolin (8), candelilla wax
(6.5), carnauba wax (3), and ozokerite (2) in descending order of predominance. The
concentrations (which need not be declared by regulation) are provided in parentheses.
The compounds of the proprietary antioxidant mixture dissolved in propylene glycol must be
integrated into the product formulation and declared individually in order of decreasing
predominance without the term "(and)."
The color additives titanium dioxide (2) etc. may be declared in any order after the other
ingredients.
Pressed Powder
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The hypothetical pressed powder formulation portrayed in this example illustrates the two
options for the listing of ingredients.
On the left side, the ingredients are listed in descending order of predominance according to
§ 701.3(2).
On the right side, the ingredients are listed according to § 701.3(f)(1), (2), and (3), i.e.,
ingredients other than colors present at a concentration exceeding 1% in descending order or
predominance, followed by ingredients other than colors present at 1% or less in any order,
followed by colors present at any concentration listed in any order.
Fragrance
Flavor
21 CFR 701.3(a)
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The components (ingredient) of a fragrance or flavor may also be declared individually by their
appropriate label names.
The ingredient or mixture of ingredients acting as a masking agent, i.e., covering the undesirable
off-odor of a product without adding a discernable odor to it, may be declared by their individual
name(s) or as "fragrance" (in lieu of a better designation). A masking agent present in a product
at an insignificant level may be considered an incidental ingredient under § 701.3(1)(2)(iii) in
which case it need not be declared on the label.
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21 CFR 701.3(a)
The FP&L Act states in section 5(c)(3)(B) [15 U.S.C. 1454(c)(3)(B)] that "nothing ... shall be
deemed to require that any trade secret be divulged." Accordingly, the cosmetic ingredient
labeling regulation does not require the declaration of the identity of an ingredient FDA has
accepted as exempt from public disclosure. In lieu of the declaration of the name of a
confidential ingredient, the phrase " and other ingredients" may be used at the end of the
ingredient declaration.
The policy the agency is following for processing requests for confidentiality of cosmetic
ingredient identities has been codified under § 720.8.
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21 CFR 20.61
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The question "what is a trade secret" may be answered by restating the definition of the term
"trade secret" as provided in § 20.61(a) of regulations published in 1974 for enforcement of the
law commonly known as the "Freedom of Information Act" (the public information section of
the Administrative Procedures Act; 5 U.S.C. 552).
1. Submission of information
Cosmetic formulation or raw material composition statement (Form 2512
OR 2513)
21 CFR 720.8
The first step in processing a request for trade secrecy, i.e., a request for exemption from label
declaration, of the identity of a cosmetic ingredient is the submission to FDA of the following
information:
(a) A semi-quantitative cosmetic formulation statement of the product in question on forms FD-
2512 and 2512a.
(b) A full statement of the factual and legal grounds for the request, including all data and other
information on which the petitioner relies (as well as any information known to the petitioner
that is unfavorable to petitioner's position).
The statement of factual grounds should include scientific or technical data, reports, tests, and
other relevant information that address the factors FDA considers in determining whether the
identity of an ingredient qualifies as a trade secret. (The factors FDA considers are stated
elsewhere.)
(c) A statement that the identity of the ingredient in question has not previously been disclosed
to anyone without appropriate safeguards for secrecy as further explained in § 20.81.
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1. Submission of Information
Cosmetic formulation or raw material composition statement (Form
2512 or 2513)
21 CFR 720.8
FDA reviews the submitted information to determine whether the data are sufficient to permit a
review of the merits of the request.
A request that contains insufficient data to conduct a confidentiality review on the merits is
returned and petitioner is advised about the additional information that is necessary to enable
the agency to proceed with the review of the request.
1. Submission of information
Cosmetic formulation of raw material composition statement (Form 2512
or 2513)
21 CFR 720.8
When the submitted information is sufficient to permit a review of the merits of a request, FDA
proceeds with the review.
When the agency concurs with petitioner and decides that the ingredient identity is a trade
secret, the request for exemption from label disclosure is granted. If FDA does not concur with
petitioner, the agency tentatively denies the request. The person requesting trade secrecy is
informed in writing of the agency's determination. In case of a tentative denial, FDA informs
petitioner of the grounds on which it relied in making this tentative determination.
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When FDA reviews the merits of a confidentiality request and determines whether the identity
of an ingredient qualifies as a trade secret, it considers the following three principal factors by
seeking answers to the following three questions:
3. Can the identity of the ingredient readily be acquired by legal means and its intended use
duplicated?
These questions are based on the factors considered in Comment B to section 757 of the
Restatement of Torts in determining whether given information is a trade secret.
Since the same factors are also being considered by FDA in determining whether the identity of
an ingredient qualifies as a trade secret, a person requesting trade secrecy must address them
factually and convincingly in the statement of grounds.
Absence of public knowledge of an ingredient's identity under conditions of intended use may be
demonstrated by documenting the extent to which the information is known by employees or
others in petitioner's business, the extent the information is publicly disclosed in pertinent
literature, and the extent of measures taken by petitioner to guard the secrecy of the
information.
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The value of knowing the identity and intended use of the ingredient in question may be
determined in terms of the importance of the ingredient to the product formulation. It must be
assumed that, to be of value, the ingredient significantly contributes to the claimed performance
or other pertinent characteristics of the cosmetic and that a cosmetic not containing the claimed
trade secret ingredient, or containing conventional substitutes in place of the respective
ingredient, could not be expected to perform equally well or otherwise meet certain
requirements. Appropriate comparative testing of a cosmetic containing the trade secret
ingredient, or one containing conventional substitutes, as well as testing of petitioner's cosmetic
against competitor's cosmetic of the same use category may provide factual documentation to
this effect and thus demonstrate the value of the information to petitioner. The value of the
ingredient information may also be determined in terms of future market performance of a
cosmetic or its profitability. However, this kind of value assessment is usually a difficult and
inexact task and often provides little factual data to support a value assessment.
Documentation of the effort expended and financial resources invested in the development of
the product formulation containing the ingredient in question and providing the claimed
characteristics may further support a request for trade secrecy.
The factor concerning the ease or difficulty with which the identity of the ingredient in question
could properly be acquired or duplicated by others may be addressed by documenting an
ingredient's rare or unexpected use for the intended purpose in cosmetics of a particular product
category or by demonstrating the complexity of the analytical methodology necessary to identify
it.
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21 CFR 720.8
When FDA tentatively decides to deny a request, the petitioner may withdraw the records for
which FDA has tentatively denied a request for confidentiality. Petitioner may also submit,
within 60 days from the date of receipt of the written notice of the tentative denial, additional
relevant information and arguments and request that the agency reconsider its decision in light
of both the additional material and the originally submitted information.
If the petitioner submits new data, the agency considers that material together with the initially
submitted information and makes its final determination. This constitutes final agency action.
The petitioner is informed of the agency's final determination in writing.
1. Submission of Information
Cosmetic Formulation or Raw Material Composition Statement (Form
2512 OR 2513)
21 CFR 720.8
The agency's final decision may be challenged in the courts under 5 U.S.C., Chapter 7. If suit is
brought within 30 days after such determination, FDA will not disclose the records involved
until the matter is finally determined in the courts. If suit is not brought within 30 days and the
petitioner does not withdraw the records for which a request for confidentiality has been denied,
the records involved will be made part of FDA's files and will then be available to the public
upon request.
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It should be noted that until the agency has completed its determination that the identity of a
cosmetic ingredient is a trade secret, the cosmetic product in question may not bear the label
statement "and other ingredients" in lieu of a declaration of the identity of the ingredient for
which confidentiality has been requested. The phrase "and other ingredients" may be used on
the label only after an ingredient is accepted by FDA as exempt from public disclosure or, when
confidentiality has been denied, if suit is brought within 30 days after a final determination that
the ingredient in question is not a trade secret.
Declaration
1. The established name of any active drug ingredient and the quantity, kind,
and proportion of any alcohol, in compliance with Sec. 502(e) of the FD&C
Act, as "Active Ingredients"
21 CFR 701.3(d)
A product intended to be applied to the human body for cleansing, beautifying, promoting
attractiveness, or altering the appearance is a cosmetic. If this product claims to accomplish
these deeds through physiological activity or by changing the structure of the skin, it is also a
drug. The product categories "drug" and "cosmetic" are not mutually exclusive. This is
recognized in sec. 509 of the FD&C Act.
If a cosmetic is also a drug, the label must list first the established name of the drug
ingredient(s) and the quantity, kind and proportion of any alcohol, in compliance with sec.
502(e) of the FD&C Act, as "Active Ingredients" and then the remaining ingredients, in
compliance with § 701.3(a) or (f), as "Cosmetic Ingredients."
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Aerosol Antiperspirant
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Bentone 38 SD Alcohol 40
Propane
Quaternium 18 Hectorite
This hypothetical aerosol antiperspirant formulation illustrates on the right side the correct label
declaration of the ingredients of a cosmetic which is also a drug.
Listed after the declaration of other color additives and after the phrase"May
contain"
A color additive(s) that is added to a cosmetic during manufacture for the purpose of color
matching may be declared on the label of each batch or lot even if not present in each.
The color additive sometimes added for color matching is listed after the declaration of other
color additives, or at the end of the declaration, and after the phrase "May Contain."
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Toilet Water
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Water Water
Fragrance Fragrance
May contain:
This hypothetical toilet water formulation in which D&C Yellow No. 10 is added to some batches
for the purpose of color adjustment shows on the right side the correct label declaration of the
color additive D&C Yellow No. 10.
Incidental Ingredients
Definition:
Any processing aid added and removed or converted to a declared ingredient
or
Any ingredient of another ingredient or processing aid present at an insignificant
level and having no technical or functional effect
1. A substance added during manufacture and removed from the cosmetic in accordance with
good manufacturing practices before the cosmetic is packaged in finished form. Example: Filter
aid.
3. A substance added to a cosmetic during manufacture for its technical effect in processing but
present in the finished cosmetic at an insignificant level and not having any technical or
functional effect in that cosmetic. Example: Defoaming agent.
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Examples:
Gift set of makeup assortment
Hair coloring kit or home permanent
Declaration:
On outside retail package only if components are not customarily sold individually.
A MULTICOMPONENT package is "a package which contains the integral components making
up a complete kit, and which is designed to deliver the components in the manner of an
application." See 21 CFR 701.13(g)(2). Examples: A hair coloring kit consisting of dye solution
and hydrogen peroxide or a permanent wave set consisting of thioglycolate solution and sodium
bromate solution.
Dissimilar products
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For the purpose of cosmetic ingredient labeling and to take advantage of provisions for
consolidated ingredient listing in place of somtimes repetitive listing of ingredients unit by unit,
a distinction must be made between packages containing:
1. Dissimilar products. Example: Gift set containing a shave cream and an after shave lotion.
2. Products of similar composition and intended for the same use in a package with a total
surface area available for labeling of 12 square inches or more. Example: Two toilet waters
of different fragrance or color in gift set.
3. Products of similar composition and intended for the same use in a package with a total
surface area available for labeling of less than 12 square inches. Example: Eye shadows of
different color in a compact case.
4. Products that are single units or assortments of a branded shade line. A branded shade line is
a series of products of similar composition, intended for the same use, and sharing a common
label with the same brand name. Example: A shade line of lipsticks.
Alternate Declaration
Single composite list of color additives with statement that list pertains to all
products
21 CFR 701.3(h)
The package of an assortment of dissimilar products, i.e., a multiunit package, as, for example, a
toilet water and a dusting powder in a gift box, may bear:
An alternate ingredient declaration in which the color additives of all products of the
assortment are integrated into a single composite list that indicates that the list pertains to all
products.
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Please note that if the units of an assortment are customarily separated from the outer package
for retail sale, the ingredients must also be declared on the label of each inside unit.
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SD Alcohol 40 SD Alcohol 40
Water Water
Fragrance Fragrance
This example of a hypothetical assortment of dissimilar products consisting of a toilet water and
a dusting powder illustrates on the right side the alternate ingredient labeling option in which all
color additives are declared in a single composite list. The declaration advises that the color
additives pertain to both products.
If, for example, Red 40 or Blue 1 were present in both products, they would have to be listed only
once in the declaration.
Alternate Declaration
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An assortment of products of similar composition and intended for the same use in a package
with a total surface area available for labeling of 12 square inches or more as, for example,
two toilet waters of different fragrance or color in a gift set, may bear either:
A conventional ingredient declaration in which the ingredients of each product are identified
under appropriate product headings, listing either all the ingredients in descending order of
predominance according to § 701.3(a) or listing the ingredients according to § 701.3(f), declaring
first in descending order the ingredients other than colors present at concentrations exceeding
1%, followed in any order by the ingredients other than color present at concentrations of 1% or
less, followed in any order by the color additives present at any concentration, or
1. The ingredients other than colors common to all products in cumulative descending order of
predominance according to § 701.3(a), or according to § 701.3(f) [permitting listing of
ingredients present at 1% or less in any order], followed by
2. The ingredients other than color not common to all products, identified by the products in
which they are present, followed by
3. The color additives of all products without identification of products in which they are
present.
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Alternate Declaration
or
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An assortment of products of similar composition and intended for the same use in a package
with a total surface area available for labeling of less than 12 square inches as, for example,
several eye shadows in a compact, may bear either:
A conventional ingredient declaration in which the ingredients of each product are identified
under appropriate product headings, listing either all the ingredients in descending order or
according to § 701.3(a) or listing the ingredients according to § 701.3(f), declaring first in
descending order the ingredients other than colors present at concentrations exceeding 1%,
followed in any order by the ingredients other than color present at concentrations of 1% or less,
followed in any order by the color additives present at any concentration,
or
An alternate ingredient declaration listing the ingredients of all products in a single integrated
list in cumulative descending order of predominance according to § 701.3(a), or cumulatively
according to § 701.3(f).
Alternate Labels
Label Copy Labeling Area 12 Sq. In. or More Labeling Area Less Than 12 Sq. In.
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Label Copy Labeling Area 12 Sq. In. or More Labeling Area Less Than 12 Sq. In.
Zinc Stearate
Kaolin
Mineral Oil
Lanolin
Titanium Dioxide
Ultramarine Green
Chromium Hydroxide Green
This example of an assortment consisting of two similar hypothetical eye shadow formulations
demonstrates the optional ingredient declarations for packages with a total surface area
available for labeling of 12 square inches or more (center) and for packages with a total
surface area available for labeling of less than 12 square inches (right side).
On the left side are shown two conventional ingredient declarations, each representing one
shade.
In the center is shown the integrated ingredient declaration for the two shades in the package
with 12 square inches or more of available labeling area. Note that the ingredients other
than color not common to all products are listed after the ingredients that are common and are
identified by the products in which they are used. (Bentonite in Blue Shade, Lanolin in Green
Shade.)
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On the right side is shown the integrated ingredient declaration for the two shades in the
package with less than 12 square inches of available labeling area. Note that the ingredients
not common to all formulations need not be identified by the products in which they are used.
Definition:
According to §§ 701.3(g)(2) and (o)(3), a branded shade line may be defined as a line of
individually packaged eye or facial make-up cosmetics or nail enamels bearing a label that is
shared with other products, i.e., bearing the same product name. Example: A line of lipsticks
with the same brand name.
According to §§ 701.3(g)(2) and (o)4), a branded shade line assortment may be defined as
several assortments of eye or facial make-up cosmetics or nail enamels in packages bearing the
same label. Example: Several compacts with the same name and label, each containing several
eye shadows.
According to 701.3(g)(2) and (o)(4), a branded shade line assortment may be defined as several
assortments of eye or facial make-up cosmetics or nail enamels in packages bearing the same
label. Example: Several compacts with the same name and label, each containing several eye
shadows.
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Alternate Declaration
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Branded shade lines and branded shade line assortments may bear either:
A conventional ingredient declaration for each product in which the ingredients of each
product are identified in descending order of predominance according to § 701.3(a) or,
alternately, according to § 701.3(f) [in the case of an assortment the ingredients may be declared
cumulatively in a single list for each assortment according to §§ 701.3(a) or (f)]
or
An alternate ingredient declaration listing all ingredients for all branded shades in the
cumulative order shown below. In this case, each shade of a branded shade line or each package
of a branded shade line assortment bears the same ingredient declaration.
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Beeswax Beeswax
Ozokerite Ozokerite
Sorbitan Trioleate Sorbitan Trioleate in Pearl Peach and Pearl Cherry Shades
Mica (and) Titanium Dioxide (and) Iron Oxides D&C Red No. 21
D&C Red No. 27 Aluminum Lake D&C Red No. 6 Barium Lake
D&C Orange No. 5 Aluminum Lake D&C Red No. 7 Calcium Lake
D&C Yellow No. 10 Aluminum Lake D&C Red No. 27 Aluminum Lake
This example of a hypothetical shade of a line of lipsticks bearing the same brand name
illustrates three common errors found in cosmetic ingredient declarations, namely:
2. Many labels list all color additives of a shade line after the phrase "May contain." The color
additives common to all shades must be listed before "May contain", and only those not found
in all shade formulations may be listed after "May contain."
3. The ingredients other than colors which are not included in all shade formulations must be
identified as to the shades in which they are present.
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Definition
Direct mail cosmetics may utilize off-package ingredient labeling as an alternative to the
declaration of ingredients on an information panel.
For the purpose of cosmetic ingredient labeling, direct mail cosmetics are defined as cosmetics
ordered by mail and delivered to consumers through the mail without the involvement of an
intermediary sales agent.
Cosmetics sold to consumers through "door-to-door" salespersons are not considered direct mail
cosmetics even though they may be delivered to consumers directly by mail.
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Declaration on
or
Labeling that accompanies and specifically relates to the cosmetic(s) mailed, e.g., a brochure,
insert or written directions for safe use, or
Labeling furnished to each consumer for personal use and from which cosmetics are ordered
through the mail, e.g., a direct mail sales catalog or brochure.
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Requirements
21 CFR 701.3(r)
If the ingredients of cosmetics distributed to consumers by direct mail are made available
through off-package labeling, the following requirement must be met:
2. The mail order distributor must promptly mail a copy of an ingredient declaration to any
person requesting it.
3. The notice in 3/16 of an inch lettering must be located on, or affixed to, the top of the package;
or it must be inside the package on top of the contents or on the face of the platform surrounding
and holding the product(s) and must be readily visible to the consumer on opening.
4. The ingredient declarations must be conspicuous and presented in a way that the consumer
can readily associate each ingredient declaration with each cosmetic.
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21 CFR 701.3(i)
(2)The total package surface area is less than 12 square inches, and
(3)The products are held for sale in tightly compartmented trays or racks.
The ingredient declaration must be in letters not less than 1/16 of an inch in height and may
appear on padded sheets, leaflets or similar labeling accompanying the product.
Products which are not eye or facial make-up cosmetics or nail enamels must be displayed for
sale in tightly compartmented trays or racks of a display unit. The holder of the padded sheets or
leaflets bearing the ingredient declaration(s) must be attached to the display unit.
Products which are eye or facial make-up cosmetics or nail enamels may be held for sale in
tightly compartmented trays or racks located below the sales counter. The holder of the
ingredient labeling must be attached to a display chart which bears samples of the product
shades and is displayed to purchasers.
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Holder of Labeling
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1. Must bear the following statement visible after last list has been taken:
"Federal law requires ingredient list to be displayed here."
21.CFR 701.3(j)
Among the various conditions described in §§ 701.3(j) and (k) that must be met if off-package
ingredient labeling is utilized as an alternative to the declaration of ingredients on an
information panel, the following deserve particular attention:
1. The display unit or chart must bear the statement "Federal law requires ingredient lists to be
displayed here" in letters not less than 3/16 of an inch in height. This statement becomes
conspicuous when the last ingredient list has been taken or may also be shown at all times
adjacent to the holder of labeling bearing the ingredient declaration(s).
Holder of Labeling
2. Padded sheets or leaflets must be attached to the display unit and be fully visible
on the front
or
partially visible on the front and bear a notice in 3/16-inch lettering describing
their location
or
2. The holder of off-package cosmetic ingredient labeling, e.g., padded sheets or leaflets, must be
attached to the display unit or chart so that the labeling is in front of the display unit or chart
and can be read in full by a purchaser facing the display under customary conditions of retail
sale.
As an alternative to full display of off-package ingredient labeling, the labeling may also be on
the side of the display unit or chart, but not at the top, back or bottom, in which case it must be
accompanied by a conspicuous notice in 3/16 of an inch lettering on the front of the display unit,
describing the location of the off-package labeling and stating "Federal law requires ingredient
lists to be displayed here."
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Additional Requirements
1. Leaflets must bear declarations of all products sold with display unit or chart.
The following additional conditions must be met to comply with the requirements for off-
package ingredient labeling of cosmetics:
1. The padded sheets or leaflets attached to the display unit or chart must declare the ingredients
of all products sold with the display.
Additional Requirements
4. Leaflets must be sufficient in number and replaced with refills with replacement
instructions to retailer.
21 CFR 701.3
3. The number of copies of padded sheets or leaflets provided with each shipment of a cosmetic
must be sufficient so that each purchaser may obtain a copy of an ingredient declaration.
Further, the display units and replacement labeling must be accompanied by appropriate
instructions to the retailer to assure that retailers display the padded sheets or leaflets.
Additional Requirements
21 CFR 701.3
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5. The firm engaged in off-package cosmetic ingredient labeling must promptly mail a copy of
the ingredient declaration to any person requesting it.
6. In case of a formulation change, the new padded sheet or leaflet must be dated if not shipped
together with the display unit or chart. If a padded sheet or leaflet is to be used in conjunction
with the old and the new formulations, it must bear both ingredient declarations, and the
declarations must be identified in a way that the purchaser can determine which declaration
pertains to which product. As an alternative, the padded sheet or leaflet bearing the two
ingredient declarations may advise the purchaser that the formulation has been changed and
that either declaration may be applicable.
https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide#top 50/50