Overview of U.S. Cosmetics Labeling Law
Cosmetics sold in the United States are regulated under the Fair Packaging and Labeling Act (FPLA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act), with the Modernization of Cosmetics Regulation Act (MoCRA) adding new requirements. The FDA enforces these regulations primarily through import inspections and post-market surveillance.
Required Label Elements
Mandatory on Every Cosmetic Label for the U.S. Market
- ✅ Identity statement (product name and type)
- ✅ Net quantity of contents
- ✅ Ingredient declaration (INCI format)
- ✅ Name and place of business of manufacturer, packer, or distributor
- ✅ Directions for safe use (where needed)
- ✅ Required warning statements (where applicable)
Ingredient Declaration — INCI Format
All cosmetic ingredients must be declared using INCI (International Nomenclature of Cosmetic Ingredients) names where established, in descending order of predominance. Below 1% concentration, ingredients may be listed in any order after those above 1%.
Key INCI rules for the U.S. market:
- Color additives must be listed with their specific U.S. name (e.g., "Titanium Dioxide" not just "CI 77891")
- Fragrance ingredients can be listed collectively as "Fragrance" or "Parfum" (but MoCRA may require individual allergen disclosure — rule pending)
- Flavors can be listed as "Flavor"
- Trade secret ingredients may be listed as "and other ingredients" with prior FDA authorization
Net Quantity Requirements
Net quantity must appear on the principal display panel (PDP) in the lower 30% of the label. For the U.S. market, it must be expressed in:
- Weight: both ounces (oz) and grams (g), e.g., "Net Wt. 1.7 oz (48 g)"
- Volume: both fluid ounces (fl. oz.) and milliliters (mL), e.g., "Net Contents 3.4 fl. oz. (100 mL)"
Cosmetic vs. Drug Claims — Critical Distinction
A product's label claims determine whether it is regulated as a cosmetic or a drug (or both). This has enormous regulatory implications.
Cosmetic Claims (Acceptable)
- "Moisturizes skin"
- "Adds shine to hair"
- "Smooths the appearance of fine lines"
- "Temporarily reduces the appearance of wrinkles"
"Prevents wrinkles" — implies physiological effect
"Stimulates hair regrowth" — treats a condition
"Anti-aging at the cellular level" — implies structural change
"Repairs damaged skin" — drug claim
Required Warning Statements
Certain cosmetic products require specific warning statements on the label by regulation:
- Aerosol products: "Warning — Do not use near fire or flame"
- Products containing alpha hydroxy acids (AHA): Sun sensitivity warning
- Products containing coal tar: Cancer and eye safety warnings
- Feminine deodorant sprays: Specific FDA-required warning
- Bubble bath products: Genital irritation warning for children's products
Label Language Requirements
All required label information must appear in English. If a foreign language is also used, all required information must appear in both languages. You cannot use a foreign language for required information and only provide the English version separately.
MoCRA's New Fragrance Allergen Disclosure
MoCRA requires the FDA to establish regulations for fragrance allergen labeling. When finalized, this will likely require disclosure of specific fragrance allergen ingredients (rather than just "Fragrance") on labels. This rule is currently under development.