FDA Cosmetics Labeling Requirements

Cosmetic products distributed in the US must comply with FDA labeling regulations under the FD&C Act, FPLA, and MoCRA 2022. Non-compliant labels result in import detention and FDA warning letters.

FD&C Act · FPLA MoCRA 2022 Ingredient Naming Since 2009

FDA Cosmetic Labeling Requirements

The cosmetics distributed in the United States must comply with the labeling regulations published by the FDA under the authority of the FD&C Act and the FP&L Act. Labeling means all labels and other written, printed, or graphic matter on or accompanying a product.

Under the FD&C Act and FPLA, required label elements include:

Product identity: Statement of what the product is
Net quantity of contents: Weight, measure, or count
Manufacturer, packer, or distributor name and address
Ingredient list: In descending order of predominance
Required warning statements — As applicable
Proper label formatting and placement: PDP and information panel requirements

The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions. This definition includes skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpaste, deodorants, and any material intended for use as a component of a cosmetic product.

Products that are cosmetics but are also intended to treat or prevent disease, or affect the structure or functions of the human body, are also considered drugs and must comply with both the drug and cosmetic provisions of the law. Examples of products that are drugs and cosmetics are anticaries toothpastes (e.g., “fluoride” toothpastes), suntanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos.

A cosmetic is considered misbranded if its labeling is false or misleading, if it does not bear the required labeling information, or if the container is made or filled in a deceptive manner.

At Liberty Management Group, our regulatory specialists identify non-compliances, and deliver corrected, ready-to-use FDA-compliant cosmetic labels accurately and efficiently.