Cosmetics Overview

Cosmetics Overview
Overview
This page provides an overview of cosmetics and the requirements that the FDA
verifies/enforces at the time they are imported or offered for import into the United
States. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) Office of
Cosmetics and Colors is responsible for overseeing the cosmetic program. Visit
the Cosmetics page for more information.
 What is a cosmetic?
 What cosmetic requirements are verified at the time of importation?
 How can I determine if a cosmetic is listed on an import alert?
 How does FDA verify compliance with the cosmetic requirements?
 Cosmetic Labeling
 Color Additives
 Voluntary Cosmetic Registration Program
 Affirmation of Compliance codes for cosmetics
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What is a cosmetic?
The FDA defines a cosmetic as a product (excluding pure soap) intended to be applied to
the human body for cleansing, beautifying, promoting attractiveness, or altering the
appearance. Cosmetics offered for import into the United States must comply with the
same FDA laws and regulations as those that are produced domestically in the United
States.
If you are unsure if a product is a cosmetic or a drug, visit the Is It a Cosmetic, a Drug, or
Both? (Or Is It Soap?) page for more information.
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What cosmetic requirements are verified at the time of importation?
The FDA conducts field examinations and collects samples of cosmetics to verify that
the products and ingredients are suitable and safe for their intended use (e.g. a color
additive in an eye shadow has been approved for use around the eye).
If a cosmetic contains color additives that require certification, the FDA will verify the
Color Identification Numbers (CIN).
If a cosmetic establishment has voluntarily registered and the registration number is

supplied, it will be verified. See below for more information on the voluntary cosmetic
registration program.
For more information visit the information for cosmetics importers page.
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How can I determine if a cosmetic is listed on an import alert?
The FDA provides a list of import alerts by industry. To view the list of import alerts
related to cosmetics visit the import alert for cosmetics page.
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How does FDA verify compliance with the cosmetic requirements?
FDA entry reviewers are trained to verify compliance with cosmetic requirements using
the information provided to the FDA in the importer’s entry transmission such as:
 Declared Manufacturer
 Declared Importer/Consignee
 Product Description
 Affirmations of Compliance (A of C)
These entry declarations are compared to information in the FDA’s internal data
systems. The submission of correct and accurate entry data along with the relevant A of
C codes will help expedite the entry review process. Supplying this information
accurately increases the likelihood that the shipment will be processed electronically
and not held for manual review because the FDA’s screening tool, PREDICT, can verify
the declared information against the FDA's internal data systems.
Note: Submitting inaccurate or incomplete information may delay the review of the
entry.
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Cosmetic Labeling
Product labels and/or labeling are reviewed to ensure the required information is
present and declared properly, it is informative and truthful, and it is in English (or
Spanish in Puerto Rico). For more information on required cosmetic labeling
information, please visit the Labeling Regulations page.
Additionally, if the label and/or labeling includes claims to treat or prevent disease or
otherwise affect the structure or any function of the body, it could cause the product to
be considered a drug. For more information on drug claims, refer to Is It a Cosmetic, a
Drug, or Both? (Or Is It Soap?) page.
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Color Additives
Color additives are permitted in cosmetics only if the FDA has approved those additives
for the intended use. If a cosmetic contains a color additive, it must adhere to the FDA’s
laws and requirements for approval, certification, identity and specifications, and use
and restrictions. The FDA separates approved color additives into two categories: colors
subject to certification and colors not subject to certification. For color additives that are
subject to certification, the FDA will verify the Color Identification Number (CIN) at the
time of importation.
Please visit the Color Additives and Cosmetics page for more information.
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Voluntary Cosmetic Registration Program
The FDA’s Voluntary Cosmetic Registration Program (VCRP) is a reporting system for
use by manufacturers, packers, and distributors of cosmetics that are in commercial
distribution in the United States. The VCRP provides the FDA information about
cosmetics and ingredients, their frequency of use, and firms involved in their
manufacture and distribution to evaluate cosmetic products on the market.
For more information on VCRP, please visit the Voluntary Cosmetic Registration

Program page.
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Affirmation of Compliance codes for cosmetics
Affirmation of Compliance codes (A of C) are three letter codes that can be provided at
the time of import to facilitate FDA review. Submission of A of C codes is not
mandatory for cosmetics, however, submitting voluntary A of C codes may expedite
initial screening and review of the entry.
Voluntary A of C codes used for cosmetics include:
 COS (Cosmetic Registration Number)
For information, including a full list of cosmetic affirmation of compliance codes, refer
to the ACE affirmations of compliance document. To determine the optional A of C’s
for the product, refer to the Industry Quick Reference Guide to the FDA ACE
Supplemental Guide.
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Useful Links
 FDA ACE External Outreach Presentation-Cosmetics
 Automated Commercial Environment/International Trade Data System (ACE/ITDS)
 Information for Cosmetics Importers
 Cosmetic Labeling Guide
 Prohibited & Restricted Ingredients in Cosmetics
 Cosmetics FAQs
Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
Using Cosmetics Safely
People use cosmetics to keep clean and enhance their beauty. These products range
from lipstick and nail polish to deodorant, perfume, hairspray, shampoo, shower gel,
tattoos, hair adhesives, hair removal products, hair dyes, most soaps, some tooth
whiteners, and some cleansing wipes. It’s important to use cosmetics products safely.
The U.S. Food and Drug Administration (FDA) reminds you to get the facts before using
cosmetics products.
 General Tips
 Eye Make-Up Tips
 Understanding Cosmetic Labels
 Report Problems to FDA
General Tips
Follow these safety guidelines when using cosmetics products of any type:
 Read the label. Follow all directions and heed all warnings.

 Wash your hands before you use the product.
 Do not share makeup.
 Keep the containers clean and tightly closed when not in use, and protect
them from temperature extremes.
 Throw away cosmetics if there are changes in color or smell.
 Use aerosols or sprays cans in well-ventilated areas. Do not use them while
you are smoking or near an open flame. It could start a fire.
Eye Make-Up Tips

There are special safety guidelines for using cosmetics in the eye area. Be sure to keep
these practices in mind:
 Do not use cosmetics near your eyes unless they are meant for your eyes. For
example, do not use lip liner on your eyes.
 Do not add saliva or water to mascara. You could add germs.
 Throw away your eye makeup if you get an eye infection. The makeup could have
become contaminated.
 Do not dye or tint your eyebrows or eyelashes at home. The FDA has provided for
the safe use of silver nitrate as a color additive, in professional-use only
cosmetics, to color eyebrows and eyelashes [21 CFR 73.2550]. Use is restricted to
up to 4 percent silver nitrate (by weight) in a viscous gel product. These silver
nitrate containing cosmetic products are not intended for use on persons under
the age of 16 or for application for longer than 1 minute. Furthermore, these
products are not for distribution or direct sale to consumers.
Understanding Cosmetic Labels

Being familiar with the product you are using is important. Be sure to read
the entire label, including the list of ingredients, warnings, and tips on how to use the
product safely. Also, be aware of the following terms that you may see on the label:
 Hypoallergenic: Do not assume that the product will not cause allergic

reactions. FDA does not define “hypoallergenic.”
 Organic or Natural: The source of the ingredients does not determine how
safe it is. Do not assume that these products are safer than products made with
ingredients from other sources. The U.S. Department of Agriculture (USDA)
defines what it means for cosmetics to be labeled “organic.” However, there is no
formal USDA or FDA definition for “natural.”
 Expiration Dates: The law does not require cosmetics to have an expiration
date. However, a cosmetic product may go bad if you store it the wrong way — for
example, in a place that is too warm or too moist. Marking the container with the
date you open a cosmetic may help you keep track of the age of your cosmetics.

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What defines a cosmetic according to the FDA?

What requirements are verified for cosmetics at the time of importation?

Cosmetics Overview

What cosmetic requirements are verified at the time of importation?

If a cosmetic establishment has voluntarily registered and the registration number is

How can I determine if a cosmetic is listed on an import alert?

How does FDA verify compliance with the cosmetic requirements?

Please visit the Color Additives and Cosmetics page for more information.

Voluntary Cosmetic Registration Program

For more information on VCRP, please visit the Voluntary Cosmetic Registration

Affirmation of Compliance codes for cosmetics

Voluntary A of C codes used for cosmetics include:

 COS (Cosmetic Registration Number)

Using Cosmetics Safely

 Read the label. Follow all directions and heed all warnings.

Eye Make-Up Tips

Understanding Cosmetic Labels

 Hypoallergenic: Do not assume that the product will not cause allergic

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