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What are the FDA Labeling Requirements for Cosmetic Products?

Updated:
August 6, 2021

The Food and Drug Administration (FDA) is an organization dedicated to protecting our health. As producers of cosmetics (including soap and aromatherapy products), it’s your responsibility to comply with the regulations and labeling requirements outlined by the FDA.

The information below will help you understand those guidelines and ensure your product is providing consumers with the necessary information they need to stay safe and healthy.

Keep in mind, this is not a comprehensive guide for labeling your cosmetic products, so we strongly encourage you to spend more time familiarizing yourself with FDA’s regulations after reading this article.

What category does my product fall under?

The following definitions are from the FDA website in order to help you identify your product category. Note: The categories aren’t mutually exclusive, e.g. a cosmetic can also be a drug.

Cosmetics

"Product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance." This can include makeup, shampoo and other hair products, nail products, tanning products, scrubs and other skin products, deodorants, some oral care products, perfumes, and others.

Soaps

Products mainly composed of the alkali salts of fatty acids which can be the only material that results in the product’s cleaning action. If your product meets this definition, it falls under the Consumer Product Safety Commission (CPSC) and isn’t considered a cosmetic under the law, so it won’t need to meet the FDA’s cosmetic labeling requirements. If the product is intended to moisturize the skin, make the consumer smell nice, deodorize the user’s body, or if it contains synthetic detergents, it’s a cosmetic. If it’s intended to treat or prevent disease, such as killing germs or treating skin conditions, it’s a drug.

Visit the FDA’s Soaps and Lotions page for more information on these types of products.

Aromatherapy & Essential Oils

Aromatherapy products are regulated based on their intended use: If the intended use is only to cleanse the body or aimed at a user's looks, it’s a cosmetic. If the use is therapeutic, such as treating disease or affecting the function of the body, it’s a drug. If the intended use is akin to air fresheners and scented candles, it falls under the purview of the CPSC.

Visit the FDA’s page on aromatherapy for additional information.

Drugs

"Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals."

A product that fits under both the drug and cosmetic description, such as fluoride toothpastes, antiperspirant deodorants, anti-dandruff shampoos, etc., will need to comply with both sets of regulations.

Still not sure which category your product would fall under? Check here for more information.

How do I label my cosmetics to comply with the FDA?

The FDA’s comprehensive cosmetic labeling guide includes sections on label placement and label content, as well as prominence, type size and ingredient lists. We’ve summarized some of the most important points:

  • Necessary content includes the name of the product, net quantity of the contents, directions for safe use, any warnings, an ingredient list, and the business information.
  • The FDA guidelines require you list the ingredients in weight order, from heaviest to lightest, and under their most commonly accepted industry standard names.
  • The products that require a warning and/or directions for safe use must have the information displayed in a noticeable and prominent way.
  • If there’s more than one label, the required information must be on the principal display panel (the label most likely to be shown under customary conditions for sale).
  • The label has to be large enough that the required information is prominently displayed in a type size that is easy to read.
  • The FDA hasn’t defined and doesn’t regulate the terms, “natural” or “organic,” but keep in mind your labeling has to be truthful and not misleading. However, the U.S. Department of Agriculture (USDA) does regulate the term “organic” under the National Organic Program (NOP).

The FDA has created a small business and homemade cosmetics fact sheet for more frequently asked questions.

Get started on your product labels easily with one of our FDA-compliant pre-designed cosmetic label templates.

Originally Published HERE.

Resources:

Small Businesses & Homemade Cosmetics: Fact Sheet

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