Tattoo Ink and Permanent

Makeup Labeling Guide

Association of Food and Drug Officials

Body Art Committee

2019
Table of Contents
Introduction………………………………………………………………………………………..3
Background……………………………………………………………………….……………….3
Scope and Application ……………………………………………………………………….…...3
Definitions…………………………………………………………………………………………4
Labeling Requirements……………………………………………………………………….…...6
Principal Display Panel…………………………………………………………………...……….7
Product Name……………………………………………………………………….……..7
Identity Labeling…………………………………………………………………………..8
Warning Statement for any Product with Unsubstantiated Safety (740.10 Warning)….....8
Declaration of Net Quantity of Contents…………………………………….……………8
Information Panel…………………………………………………………………………….……9
Directions for Safe Use…………………………………………………………………....9
Warnings…………………………………………………………………………………..9
Name and Place of Business……………………………………………………...…..….10
Ingredient Declaration……………………………………………………………...……11
Other Suggested Information………………………………………………….…………12
Placement of Information on Labels……………………………………………………………..13
Exemptions from Labeling Requirements……………………………………………………….13
Professional Use Labeling……………………………………………………………….14
Misbranding………………………………………………………………………………..…….14
Examples of Labels.………………………………………………………………………….…..15
Appendix I……………...……………………………………………………………………..…17
References……………………………….………………………………………………....…….24

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Introduction
The purpose of the Association of Food and Drug Officials – Body Art Committee Tattoo Ink
and Permanent Makeup Labeling Guide is to assist with tattoo ink and/or permanent makeup
labeling and answer questions about labeling requirements under the applicable regulations.
This document was created by the Association of Food and Drug Officials - Body Art
Committee and as such, does not establish any legally enforceable responsibilities. Instead, this
guide presents suggested information to include on tattoo ink or permanent makeup labels and
other information that may be helpful to individuals and entities involved in the creation, use and
regulation of tattoo ink or permanent makeup labels. Except when specific regulatory or statutory
requirements are cited, the information presented in this document should be viewed only as
recommendations by the Association of Food and Drug Officials - Body Art Committee.

Background
The inks used in intradermal tattoos, including permanent makeup, generally qualify as both
"cosmetics" and "color additives." Under section 201(i) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) [21 U.S.C. § 321(i)], the term "cosmetic" includes "articles intended to be . . .
introduced into . . . the human body or any part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance." Regulations that pertain specifically to cosmetics
appear in Title 21 of the Code of Federal Regulations, Parts 700 (General), 701 (Cosmetic
Labeling), 710 (Voluntary Registration of Cosmetic Product Establishments), 720 (Voluntary
Filing of Cosmetic Product Ingredient Composition Statements), and 740 (Cosmetic Product
Warning Statements). Under section 201(t) of the FD&C Act [21 U.S.C. § 321(t)], a "color
additive" includes "a dye, pigment, or other substance . . . when added or applied to a . . .
cosmetic, or to the human body or any part thereof, [that] is capable (alone or through reaction
with other substance) of imparting color thereto." Color additives are subject to premarket
approval under the Federal Food, Drug, and Cosmetic Act [see section 721 of the FD&C Act (21
U.S.C. § 379e)]. Regulations that pertain specifically, to color additives appear in Title 21 of the
Code of Federal Regulations, Parts 70, 71, 73, 74, and 80. Cosmetic labels must also comply
with the Fair Packaging and Labeling (FP&L) Act. Proper labeling helps consumers make
informed decisions and helps public health officials investigate outbreaks.

Scope and Application

This guidance document is meant to assist industry, professionals, and regulators with
compliance to U.S. laws and related regulations for tattoo ink or permanent makeup labeling of
products in commercial distribution in the US. An additional checklist has been included at the
end of this document to further assist in the assessment of the physical tattoo ink or permanent
makeup label for required and suggested information.

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Definitions
The following terms used in this document shall be defined as follows:
 Adulterated – A tattoo ink or permanent makeup that is contaminated, corrupted,
debased, or made impure by the addition of a foreign or inferior substance or element.
 Adverse Event – Any health-related event associated with the use of a tattoo ink or
permanent makeup that is adverse.
 Batch – A specific quantity of a tattoo ink or permanent makeup that is intended to have
uniform character and quality, within specified limits, and is produced according to a
single manufacturing order during the same cycle of manufacture.
 Body Art – The application of tattooing and/or permanent makeup.
 Body Artist or Practitioner – Any person performing body art services whether licensed
or not.
 Color Additive – A material which:
o Is a dye, pigment, or other substance that is synthesized, extracted, isolated, or
derived from a vegetable, animal, mineral, or other source.
o When added or applied to a tattoo ink, permanent makeup or to the human body,
it is capable of imparting color; unless the material is being used for something
other than coloring.
o The term “color” includes black, white, and intermediate grays.
 Common Fractions – A fraction that is expressed by a numerator and a denominator, not
decimally. Examples: halves (1/2), quarters (1/4), eighths (1/8), sixteenths (1/16), or
thirty-seconds (1/32).
 Consumer Commodity – A product customarily distributed for retail sale for use by
consumers, including tattoo ink or permanent makeup.
 Cosmetic – A product and/or constituent raw ingredients, except soap, intended to be
rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the
human body or any part thereof for cleansing, beautifying, promoting attractiveness, or
altering the appearance.
 Country of Origin – The country in which tattoo ink or permanent makeup are
formulated and or bottled.
 Decimal Fractions – The system of decimal numerical notation. A fraction whose
denominator is a power of ten and the numerator is expressed by figures placed to the
right of a decimal point.
 Fair Packaging and Labeling Act – Ensures that packages and their labels provide
consumers with accurate information about the quantity of contents and facilitate value
comparisons.
 Federal Food, Drug, and Cosmetic Act of 1938 – Protects consumers from unsafe or
deceptively labeled or packaged products by prohibiting the movement in interstate
commerce or adulterated or misbranded food, drugs, devices, and cosmetics.
 Incidental Ingredients – Substances that have no technical or functional effect in the
tattoo ink or permanent makeup but are present by reason of having been incorporated
into the tattoo ink or permanent makeup as an ingredient of another tattoo ink or
permanent makeup ingredient.
 Information Panel – Part of a label that is generally the back and side panels.

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 Intended Use – The directed or prescribed use for a product determined from the
statements made on a product’s label or labeling.
 Label – Any display of written, printed, or graphic matter on the immediate package of
any article, or any such matter affixed to any consumer commodity or affixed to or
appearing on a package containing any consumer commodity.
 Labeling – All labels, inserts, risers, display packs, leaflets, promotional literature, or any
other written, printed, or graphic information distributed with the product.
 Lot – A batch, or a specific identified portion of a batch, having uniform character and
quality within specified limits; or a specific identified amount produced in a unit of time
or quantity in a manner that assures its having uniform character and quality within
specified limits.
 Lot Number, Control Number, or Batch Number – Any distinctive combination of
letters, numbers, or symbols, or any combination of them, from which the complete
history of the manufacture, processing, packing, holding, and distribution of a batch or lot
of product or other material can be determined.
 Misbranded – Label, labeling or package is misleading in any way.
 Net quantity – The weight or mass, measure, or numerical count.
 Package – Any container or wrapping, not including shipping containers or wrappings, in
which any tattoo ink or permanent makeup, of any size, is enclosed for use in the delivery
or to retail purchasers.
 Permanent Makeup – A tattoo, whether permanent, semi-permanent, or temporary, by
someone other than a licensed physician, which includes but is not limited to eyebrows,
eyelids, lips and other parts of the body for beauty marks, hair imitation, lash
enhancement or areola repigmentation. This includes any procedures referred to as, but
not limited to, “Permanent cosmetic”, “microdermapigmentation”, “micropigment
implantation”, “microblading”, “dermagraphics”, or “cosmetic tattooing” and for the
purpose of these rules has the same meaning as “tattoo”.
 Principal Display Panel – Part of a label that is most likely to be displayed, presented,
shown, or examined under normal and customary conditions of display for retail sale.
Usually, it is the front panel of the label of the outer package, if there is an outer package.
 Professional – Licensed tattoo and/or permanent makeup artist.
 Sterile – A state of being free from viable microorganisms.
 Tattoo/Tattooing – Any method of placing ink or other pigment into or under the skin or
mucosa by the use of needles or any other instruments used to puncture the skin, resulting
in permanent or temporary colorization of the skin or mucosa. This includes all forms of
permanent makeup.
 Tattoo Ink – A color additive (dye, pigment, lake, or other substance) combined with a
carrier that is used in tattooing and permanent makeup.
 Trade Secret – Any formula, pattern, device or compilation of information which is used
in one’s business and which gives one an opportunity to obtain an advantage over
competitors who do not know or use it.
 Ultimate Purchaser – The last U.S. person who will receive the goods in the form in
which it was imported. If the goods are destined for a U.S. based processor where they
will undergo a substantial transformation, then that processor or manufacturer is
considered the ultimate purchaser.

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  Use By Date – The date by which the label of a tattoo ink or permanent makeup states
that the product must or should be used by.
Labeling Requirements
A label may consist of more than one panel. It may consist of a front panel, side panels, and a
back panel. The following are requirements when creating a label, whether it is a principal
display panel or an information panel (FP&L Act, 15 U.S.C. 1453).
 The size of each panel must be large enough to provide sufficient space for prominent
display of the required information (21 CFR 701.2 (a)).
 The style and size of letters should be at least the required minimum size and be easily
readable. The minimum size requirements are (21 CFR 701.2 (a)):

Section/Content of Labeling Font Size

Ingredients  1/16 of an inch.
 1/32 of an inch. if labeling surface is
less than 12 square inches
Net Contents  1/16 of an inch if principal display
panel is less than 5 square inches.
 1/8 of an inch if principal display
panel is between 5 and 25 square
inches
 3/16 of an inch if principal display
panel is between 25 and 100 square
inches.
Warnings  1/16 of an inch.
All Others  Reasonable related to panel size

 The background contrast must be sufficient to make the required label statements
conspicuous and easily readable (21 CFR 701.2 (a)).
 The required statements must not be obscured by vignettes, other designs, or by crowding
with other printed or graphic matter (21 CFR 701.2(a)).
 All words, statements, and other information required in the Federal Food, Drug, and
Cosmetic Act should be on the label or labeling in English. If the label or labeling
contains any representation in a foreign language, the required statements must also
appear on the label or labeling in English (21 CFR 701.2 (b); Tariff Act of 1930, 19
U.S.C. 1304).

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 Principal Display Panel
The principal display panel is the part of the label that is most likely to be displayed, presented,
shown, or examined under customary conditions of display for retail sale. The principal display
panel needs to be large enough to accommodate all of the required label information (FP&L Act,
15 U.S.C. 1453; 21 CFR 701.2).
The information that must be on the principal display panel is:
 Product Name
 Identity
 Warning Statement for any Product with Unsubstantiated Safety (740.10 Warning)
 Declaration of Net Quantity of Contents.
The area of the principal display panel should be:
 Rectangular package: one entire side (21 CFR 701.10 (a))
 Cylindrical or nearly cylindrical package: 40% of the height x circumference (21 CFR
701.10 (b))
 Any other shape of package: 40% of total package surface, excluding top, bottom, neck,
shoulder, and flanges (21 CFR 701.10 (c))
Product Name
The common or usual name must be on the label (21 CFR 701.10). “Tattoo Ink” or “Permanent
Makeup Ink” is an acceptable name. Having only the brand name without a description of the
product, however, is not acceptable.
Examples (all examples are best practice):
Acceptable

Big Blue Dog Tattoo Ink Big Blue Dog

Ruby Red Ruby Red Tattoo Ink
Tattoo Ink

Big Blue Dog Big Blue Dog Ruby Red

Acceptable

Ruby Red
Not

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Identity Labeling
The identity statement can be expressed in terms of the common or usual name, a descriptive
name, or when the nature of the product is obvious, a fanciful name (FP&L Act 15 U.S.C. 1453).
It may also be expressed in the form of an illustration.
The statement of identity should be in bold type on the principal display panel, a size reasonably
related to the most prominent information on the panel, and in line parallel to the bottom of the
package (21 CFR 701.11).
Warning Statement for any Product with Unsubstantiated Safety (740.10 Warning)
A tattoo ink or permanent makeup that’s safety has not been adequately substantiated must have
the following statement conspicuously placed on the principal display panel, or it is considered
misbranded (FD&C Act Sec 602; 21 CFR 740.10):
Warning – The safety of this product has not been determined
This statement must be in bold type, on contrasting background, and may not be less than 1/16 of
an inch in height (21 CFR 740.2).
The safety of a tattoo ink or permanent makeup may be considered adequately substantiated if
experts qualified by scientific training and experience can reasonably conclude from the
available toxicological and other test data, chemical composition, and other pertinent information
that the product will not cause harm or injury to consumers when used under customary
conditions (21 CFR 740.10 (b)).
Even if the safety of each ingredient has been substantiated, there is usually some additional
testing, such as toxicological testing, needed with the formulated product to assure adequate
safety substantiation.
Declaration of Net Quantity of Contents
The net quantity of contents should be separately and accurately stated in a uniform location
within the bottom 30% of the label parallel to the base on which the package rests, using the
most appropriate units of both the customary inch or pound system of measure and the SI metric
system (FP&L Act, 15 U.S.C. 1453; 21 CFR 701.13).
The contents should be expressed in terms of weight, measure, numerical count, or a
combination of numerical count and weight or measure (21 CFR 701.13).
The print must be legible, bold face type, and in distinct contrast to the background and other
material on the label. The type size is determined by the area of the principal display panel.
Area of Principal Display Panel Font Size (minimum)
Less than 5 square inches At least 1/16 of an inch
Between 5 and 25 square inches At least 1/8 of an inch
Between 25 and 100 square inches At least 3/16 of an inch

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If the product is in liquid form, the statement should be in terms of fluid measure. If the product
is in solid, semisolid, viscous, or a mixture of solid and liquid, the statement should be in terms
of weight (21 CFR 701.13).
Weight should be in terms of pounds and ounces while fluid measure should be in terms of US
gallon and quarts, pint, and fluid ounce subdivisions. It should express the volume at 68 deg. F
(20 deg. C) (21 CFR 701.13).
The declaration may contain common or decimal fractions which should be reduced to the lowest
common terms (21 CFR 701.13).
The declaration should not include any term qualifying a unit of weight, measure, or count that
tends to exaggerate the amount of the tattoo ink or permanent makeup in the package; for
example, “full quart” (FP&L Act, 15 U.S.C. 1453).
Examples (all examples are best practice):
 A declaration of 1 ½ pound weight should be expressed as “Net wt. 24 oz. (1 lb. 8 oz.)”,
“Net wt. 24 oz. (1 1/2 lb.)”, or “Net wt. 24 oz. (1.5 lb.)”
 A declaration of three-fourths pound avoirdupois weight should be expressed as “Net wt.
12 oz.”
 A declaration of 1-quart liquid measure should be expressed as “Net contents 32 fl. oz.
(1 qt.)”
 A declaration of 1 ¾ quarts liquid measure should be expressed as “Net contents 56 fl.
oz. (1 qt. 1 ½ pt.)” or “Net contents 56 fl. oz. (1 qt. 1 pt. 8 oz.)” but not in terms of quart
and ounce such as “Net contents 56 fl. oz. (1 qt. 24 oz.)”
Information Panel
The information panel needs to be large enough to contain the mandatory information.
The information panel must include:
 The Directions for Safe Use
 Warnings (if any)
 Name and Place of Business
 Ingredient Declaration
 Any Other Information.
Directions for Safe Use
Adequate directions for safe use must be included (21 CFR 1.21).
Examples (all examples are best practice):
 “Shake well”
 “Do not dilute”
 “Ink should be kept within a defined temperature range (insert range) to ensure product
integrity”

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Warnings
The label of a tattoo ink or permanent makeup product should have a warning statement
whenever necessary or appropriate to prevent a health hazard that may be associated with the
product (21 CFR 740.1).
Examples (all examples are best practice):
 “This product may harmful to your health or may cause an allergic reaction.”
 “Do not use on women who may be pregnant”
 “Keep out of reach of children”
 “Not to be reused – discard any leftover ink”
 “Ink should not be used if the seal is broken”
The warning statement(s) must appear on the label prominently and conspicuously as compared
to other words, statements, or designs, so that it is likely to be read and understood by the
consumer.
The lettering must be in bold type on contrasting background and in no case be less than 1/16 of
an inch (21 CFR 740.2).
Name and Place of Business
The label in package form needs to have the name and place of business of either the
manufacturer, packer, or distributor conspicuously (21 CFR 701.12). The purpose of this is so
the consumer can identify and communicate with at least one of the three.
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 applicable wording.
The name of the firm must be the corporate name and the address of the principal place of
business. The business address must include the street address, name of the city and state and zip
code (21 CFR 701.12).
Imported products, including tattoo ink or permanent makeup that are formulated or bottled in
another country, must have the country of origin declared in English on the label conspicuously.
The purpose of this is so that the ultimate purchaser, body artist or practitioner knows the
country of origin. The body artist or practitioner may or may not be the ultimate purchaser.
(Tariff Act of 1930, 19 U.S.C. 1304)
Examples include “Made in China” and “Made in Mexico”.

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Ingredient Declaration
Declaration of ingredients except flavor, fragrance, and trade secret ingredients should be listed
in descending order of predominance.
If one or more ingredients is accepted as exempt from public disclosure pursuant to the
procedure established in 21 CFR 720.8 (a), instead of label declaration of identity the phrase
“and other ingredients” may be used at the end of the ingredient declaration.
The declaration should be prominent and conspicuous, so it is easy to read (21 CFR 701.3). The
minimum sizing should be:
 Letter height: 1/16 of an inch.
 Exceptions:
o If total labeling surface area is less than 12 square inches: 1/32 of an inch.
o Information panel: 1/32 of an inch.
o Firmly affixed tag, tape, or card: 1/32 of an inch
A tattoo ink or permanent makeup ingredients should be identified in the declaration of
ingredients by one of the following (21 CFR 701.3):
 The established name as specified in 701.30
 The name adopted for the ingredient as listed in:
o PCPC-wICID (Web Based International Cosmetic Ingredient Dictionary and
Handbook) https://www.personalcareconcil.org/member-industry-
resources/winci-web-based-ingredient-dictionary
o PCP-ICID (International Cosmetic Ingredient Dictionary and Handbook, 15 th Ed.
2014)
o CTFA (Cosmetic, Toiletry, and Fragrance Association, Inc.) Cosmetic Ingredient
Dictionary
o United States Pharmacopeia
o National Formulary
o Food Chemicals Codex
o USAN and the USP dictionary of drug names
o FDA Substance Registration System Nomenclature
 The name generally recognized by consumers.
 The chemical or other technical name or description.
As an alternative to listing all ingredients in descending order of predominance, ingredients may
be grouped listed in the following manner (21 CFR 701.3):
 Ingredients, other than color additives, present at a concentration greater than 1%, in
descending order of predominance; followed by
 Ingredients, other than color additives, present at a concentration of not more than 1%,
without respect to order of predominance; followed by
 Color additives, without respect to order of predominance.
 Ingredients specified in the not more than 1% category may be included with those
specified in the greater than 1% category of this section and listed in descending order of
predominance.

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When declaring colors, the name of the color should be identified in addition to the C.I. number,
as to provide the most information to the consumer. In the ingredients declaration, if using the
C.I. number, it shall follow the color name in parentheses, which can be seen in the examples
below.
Examples (all examples are best practice):

Ingredients: Distilled Water Ingredients: Distilled Water,

(58), Glycerin (8), D&C Red No. Glycerin, Witch Hazel, D&C Red
6 (C.I. 13578)(5), Titanium No. 6 (C.I. 13578), Titanium
Dioxide (C.I. 77891)(4), Witch Dioxide (C.I. 77891), D&C
Hazel (3), D&C Orange No. 10 Orange No. 10 (C.I. 57887)
(C.I. 57887)(2)

Color additives added sometimes for color matching are listed after the declaration of other color
additives and after the phrase “May contain”.
Incidental ingredients that are present in a tattoo ink or permanent makeup at insignificant levels
and that have no technical or functional effect in the tattoo ink or permanent makeup are not
required to be declared on the label or labeling.
Other Suggested Information
Federal law does not require identification of a lot or batch. However, it is in best interest of the
manufacturer to include a lot and/or batch number on the label. If a package does not contain a
lot or batch number, then the entire production of that tattoo ink or permanent makeup would be
considered a lot. For example, if there was a recall of a specific tattoo ink or permanent makeup,
the entire lot would be subject to recall; if there is no lot number recorded, the entire production
of that tattoo ink or permanent makeup would need to be recalled.
It is advised to limit the size of batches by assigning a lot number on a routine basis. This will
allow the linking of adverse events to specific lots, therefore improving the investigation of
adverse events as well as potentially limiting the amount of product affected.
Additionally, use by dates or date coding are not required by law but are recommended to be on
the label because it is the responsibility of the manufacturer to make sure that the products are
safe. Stability testing is recommended to establish use by dates.
Having a use by date:
 Is recommended if the product deteriorates over time, creating a possible safety issue.
 Can serve as a batch ID.
 Can decrease/prevent packages from being reused.

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Placement of Information on Labels
Outer Package (or label if sold as a single bottle) as in a multilevel packaging configuration or
set of tattoo inks or permanent makeup (21 CFR 701.10, 21 CFR 701.13).

Principal Display Panel Information Panels

Name of Product Directions for Safe Use
Identity Warnings (if any)
740.10 Warning Name and Place of Business
Net Quantity of Contents Ingredient Declaration
Other Suggested Information

An Inner Package (if packaged in an outer package) is an individual bottle of tattoo ink or
permanent makeup that is part of a set. If tattoo ink or permanent makeup is sold as part of a set,
then the individual bottles should state that they are not packaged for individual resale.
Front Panel Information Panels
Name of Product Directions for Safe Use
Warnings (if any)
Name and Place of Business
Net Quantity of Contents
Other Suggested Information

Exemptions from Labeling Requirements

A shipment or delivery of a tattoo ink or permanent makeup is exempt from labeling
requirements during interstate commerce and time of holding if:
 The tattoo ink or permanent makeup in the shipment or delivery is going to be traded,
processed, labeled, or repacked in substantial quantity at an establishment other than
where originally processed or packed.
A shipment or delivery of a tattoo ink or permanent makeup is exempt from labeling
requirements during interstate commerce and time of holding if the person who introduced the
shipment or delivery into interstate commerce (21 CFR 701.9):
 Is the operator of the establishment where the tattoo ink or permanent makeup is going to
be processed, labeled, or repacked.
 Is not the operator and there is a written agreement that:

13
 o Is signed by both the person who introduced the shipment and the operator of the
establishment
o Has the address of both parties
o Contains specifications for the processing, labeling, or repacking of the tattoo ink
or permanent makeup in the establishment to ensure that the product will not be
adulterated or misbranded during processing, labeling, or repacking.
o Is provided to both parties and retained for at least two years after the final
shipment or delivery of the tattoo ink or permanent makeup from the
establishment.
A shipment or delivery that is exempt from labeling requirements becomes invalid if (21 CFR
701.9):
 The tattoo ink or permanent makeup in the shipment or delivery is adulterated or
misbranded when removed.
 The person who introduced the shipment or delivery into the interstate commerce refuses
to make a copy of the required agreement available for inspection.
Professional Use Labeling
Tattoo ink or permanent makeup that is marketed solely for use by professionals may say “for
professional use only” on the label. If the ink is only sold to and used by professionals, then it is
exempt from having the ingredient declaration on the label. However, if the tattoo ink or
permanent makeup is also made available for sale and use to non-professionals in any way, it is
no longer exempt, and it must contain the ingredient declaration on the label (FP&L Act).
Misbranding
A tattoo ink or permanent makeup is considered misbranded if the labeling (FD&C Act, Sec
602):
 Is false or misleading.
 Has a false or misleading representation with respect to another cosmetic or a food, drug,
or device.
 Does not include the name and place of business of the manufacturer, packer, or
distributor.
 Does not include an accurate statement of the quantity of the contents in terms of weight,
measure, or numerical count.
 Does not have all of the required information on the label or labeling in a way that it can
be understood by the ordinary individual under customary conditions of purchase and
use.
 Of the package is misleading.
 Or packaging is in violation of an applicable regulation.
Labeling of a tattoo ink or permanent makeup shall be deemed to be misleading if it has a label
that is deceptive or has a material fact that is not revealed on the label.

14
Examples of Labels
These example labels are best practice examples.
Label Layout Example 1

15
Label Layout Example 2

16
Appendix I – Checklist
General Label Requirements
Compliance Citation Description/Notes
(Y/N)
21 CFR 701.2 General Labeling Requirements
a(1) All required information is on the label and is displayed
under customary conditions of purchase.
a(2), a(3), a(4), Label is large enough for all required information.
a(5)
a(6) Style and size of letters is at least the minimum size and
is easily readable. (Size requirements listed in each
section).
a(6) Background contrast allows for label statements to be
conspicuous and easily readable.
a(6) Required statements are not obscured by vignettes, other
design, or by crowding with other printed or graphic
matter.
b All words, statements, and other required information
must be on the label and labeling in English.

Principal Display Panel Requirements

Compliance Citation Description/Notes
(Y/N)
21 CFR 701.10 Principal Display Panel Size
a Rectangle package: principal display is one entire side.
b Cylindrical/nearly cylindrical package: principal display
panel is 40% of the height x circumference.
c Any other shaped package: principal display panel is
40% of the total container surface (excluding top,
bottom, neck, shoulder, and flanges).

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Compliance Citation Description/Notes
(Y/N)
21 CFR 701.11 Identity Labeling

a On the principal display panel.

b In terms of the common name/usual name/descriptive

name.

c In bold type.

c Letter size is reasonably related to the most prominent

information on the panel.

c In line and parallel to the bottom of the package.

21 CFR 740.10 Warning Statement for any Product with

Unsubstantiated Safety

a Has safety been substantiated for cosmetic use for every

ingredient?
If not, then this statement is on the principal display
panel: “Warning – The safety of this product has not
been determined”.

21 CFR 740.2 Conspicuousness of Warning Statements

a In bold type.
a Letter size is at least 1/16 of an inch in height.

21 CFR 701.13 Declaration of Net Quantity of Contents

a Expressed in terms of weight, measure, numerical count,
or a combination of numerical count and weight or
measure.
a Cosmetic in liquid form?
Statement is in terms of fluid measure.
a Cosmetic is solid/semisolid/viscous/mixture?
Statement is in terms of weight.

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Compliance Citation Description/Notes
(Y/N)
21 CFR 701.13 Declaration of Net Quantity of Contents
b Statement in weight?
Statement in terms of avoirdupois pound and ounce.
b Statement in fluid measure?
Statement in terms of the U.S. gallon and quart, pint, and
fluid ounce.
d Common fractions being used?
Reduced to lowest terms.
d Decimal fraction being used?
No more than two decimal places.
e Located on the principal display panel(s).
f Appears as a distinct item and is separated from other
printed label information.
f Does not include any terms that exaggerate the amount in
the container. Ex: “full quart”.
f Within the bottom 30 percent of the label.
f In line and parallel to the base on which the package
rests.
g Accurately reveals the quantity in the package.
h In bold type.
i(1) Label size less than 5 sq. inches?
Letter size at least 1/16 of an inch in height.
i(2) Label size between 5 and 25 sq. inches?
Letter size at least 1/8 of an inch in height.
i(3) Label size between 25 and 100 sq. inches?
Letter size at least 3/16 of an inch in height.
i(4) Label size more than 100 sq. inches?
Letter size at least 1/4 of an inch in height.

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 Information Panel Requirements
Compliance Citation Description/Notes
(Y/N)
21 CFR 1.21 Failure to Reveal Material Facts/Directions
for Safe Use
a(2) Has statement(s) about what can happen when using
product. Ex. Directions for safe use.

21 CFR 740.1 Establishment of Warning Statements

a Has a warning statement to prevent a health hazard that
may be associated with the product.

21 CFR 740.2 Conspicuousness of Warning Statements

a In bold type.
a Letter size is at least 1/16 of an inch in height.

21 CFR 701.12 Name and Place of Business of

Manufacturer, Packer, or Distributor
a Specifies the name and place of business of the
manufacturer, packer or distributor.
b Is the manufacturer, packer or distributor a corporation?
Use actual corporate name. The name of the particular
division can go before or behind the corporate name.
b Is the manufacturer an individual, partnership, or
association?
Use the name under which the business is conducted.
c Using a name different than the person who
manufactured the product?
Have qualifying statement revealing connection. Ex.
“Manufactured for _____”, “Distributed by _____”, or
any other wording that expresses the facts.

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Compliance Citation Description/Notes
(Y/N)
21 CFR 701.12 Name and Place of Business of
Manufacturer, Packer, or Distributor
d Street address (unless in a current city directory or
telephone directory).
d City.
d State.

d Zip code.

21 CFR 701.3 Designation of Ingredients

a States the name of each ingredient in descending order

of predominance (fragrance or flavor may be listed as
fragrance or flavor).

b Letter size is at least 1/16 of an inch in height.

c Ingredients are identified by one of the following:

1. The established name as specified in 701.30.
2. The name adopted for the ingredient as listed in:
a. PCPC-wICID (Web Based International
Cosmetic Ingredient Dictionary and
Handbook).
b. PCP-ICID (International Cosmetic
Ingredient Dictionary and Handbook).
c. CTFA (Cosmetic, Toiletry, and
Fragrance Association Inc.) Cosmetic
Ingredient Dictionary.
d. United States Pharmacopeia.
e. National Formulary.
f. Food Chemicals Codex.
g. USAN and the USP dictionary of drugs.
h. FDA Substance Registration System
Nomenclature.
3. The name generally recognized by consumers.
4. The chemical or other technical name or
description.
*Color is declared using the color name in addition to
the C.I. number.

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Compliance Citation Description/Notes
(Y/N)
21 CFR 701.3 Designation of Ingredients

f Instead of listing ingredients in descending order of

predominance, ingredients can be listed as follows:
1. Ingredients (other than color additives) present
at a concentration greater than 1% in descending
order of predominance.
2. Ingredients (other than color additives) present
at a concentration of less than 1 % without
respect to order predominance.
3. Color additives without respect to order
predominance.
g Have a color additive that was added for color matching
purposes?
Include with the phrase “may contain” after the
declaration of other color additives.
*Reference to a website for designation of ingredients does not satisfy labeling requirements. *

Label Content Exempt if “For Professional Use Only”

Ingredient Declaration but only if not sold at retail.

Suggested Best Practice Content

Lot and/or batch number.

Use by date.

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 Suggested Best Practice Examples
Directions for Safe Use:
Shake well.

Do not dilute.

Ink should be kept within a defined stability range (insert range) to ensure product
integrity.
Warnings:
This product may be harmful to your health or may cause an allergic reaction.
Do not use on women who may be pregnant.
Keep out of reach of children.
Not to be reused – discard any leftover ink.
Ink should not be used if the original seal is broken.

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References
Code of Federal Regulations Title 21. Retrieved from https://www.ecfr.gov/cgi-bin/text-
idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tp
l
Fair Packaging and Labeling Act. Retrieved from
https://www.ftc.gov/enforcement/rules/rulemaking-regulatory-reform-proceedings/fair-
packaging-labeling-act
Federal Food, Drug, and Cosmetic Act of 1938. Retrieved from
https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/FederalFoodDrugandCosmeti
cActFDCAct/default.htm
Food & Drug Administration (FDA) Cosmetic Labeling Guide. Retrieved from
https://www.fda.gov/downloads/Cosmetics/Labeling/UCM391202.pdf
Tariff Act of 1930. Retrieved from https://www.law.cornell.edu/uscode/text/19/chapter-4

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