Overview of FDA Cosmetic Labeling Requirements
Cosmetic labeling in the United States is governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Fair Packaging and Labeling Act (FPLA), and implementing regulations in 21 CFR Part 701. The Modernization of Cosmetics Regulation Act (MoCRA) added new requirements, including fragrance allergen disclosure and contact information for adverse event reporting.
Key Principle
Principal Display Panel (PDP)
The Principal Display Panel (PDP) is the part of the label most likely to be displayed to consumers at retail. Per 21 CFR 701.11, the PDP must include:
PDP Required Elements
- Statement of identity (what the product is)
- Net quantity of contents
- Name and place of business of manufacturer, packer, or distributor
Statement of Identity
The statement of identity must:
- Identify the nature and use of the product
- Use common or usual name, or descriptive term
- Be prominently displayed on PDP
- Use type size reasonably related to most prominent printed matter
Net Quantity Declaration
Net quantity must be stated in:
- Both metric (grams, milliliters) and US customary (ounces, fluid ounces) units
- Lower 30% of PDP for packages with >5 square inches PDP
- Specific type size requirements based on package area
| PDP Area | Minimum Type Height |
|---|---|
| 5 sq in or less | 1/16 inch |
| More than 5 to 25 sq in | 1/8 inch |
| More than 25 to 100 sq in | 3/16 inch |
| More than 100 to 400 sq in | 1/4 inch |
| More than 400 sq in | 1/2 inch |
Information Panel
The Information Panel is typically the panel to the immediate right of the PDP. Per FDA labeling guidance, it must include:
Information Panel Required Elements
- Name and address of manufacturer, packer, or distributor
- Ingredient declaration
- Required warnings (if applicable)
- Directions for safe use (if necessary)
- Contact information for adverse event reporting (MoCRA requirement)
Ingredient Declaration Requirements
Under 21 CFR 701.3, cosmetic ingredient labeling must:
Order of Ingredients
INCI Names
Per PCPC INCI guidelines, ingredients should be listed using:
- INCI (International Nomenclature of Cosmetic Ingredients) names
- CTFA names (predecessors to INCI) also acceptable
- Common names acceptable if no INCI name exists
Finding INCI Names
Fragrance and Flavor Labeling
Traditionally, fragrance and flavor ingredients could be listed simply as "fragrance" or "flavor" without disclosing individual components. Under MoCRA, this is changing:
Fragrance Allergen Disclosure: PENDING
Required Warning Statements
21 CFR Part 740 requires specific warnings for certain cosmetic products:
| Product Type | Required Warning | Regulation |
|---|---|---|
| Feminine deodorant sprays | Caution: For external use only... | 21 CFR 740.11 |
| Aerosol products | Warning: Avoid spraying in eyes... | 21 CFR 740.11 |
| Coal tar hair dyes | Caution: This product contains ingredients... | 21 CFR 740.17 |
| Foaming detergent bath products | Caution: Use only as directed... | 21 CFR 740.17 |
Important MoCRA Update (July 1, 2024)
Cosmetic Products Making Drug Claims
Per FDA cosmetic vs. drug guidance:
Drug Labeling Required
MoCRA Labeling Changes
The MoCRA introduced new labeling requirements:
Adverse Event Contact Information
Under 21 U.S.C. § 364 and FDA adverse event guidance:
Required Contact Information
- US domestic address of responsible person
- Telephone number OR electronic contact (email)
- Must be displayed on product label
- Purpose: Enable consumers to report adverse events
Fragrance Allergen Disclosure (PENDING)
Status: FDA missed its statutory deadline (December 29, 2025). As of January 2026:
- Current federal requirement: None
- FDA proposed rule expected: May 2026
- Final rule likely effective: 2027 or later
- When implemented, specific fragrance allergens will need to be individually listed if above threshold levels
Professional Use Products
Products marketed for professional use only have some modified requirements:
| Requirement | Retail Products | Professional Use Only |
|---|---|---|
| Ingredient declaration | Required on label | May be on accompanying literature |
| Net quantity | Required on PDP | Required on PDP |
| Warnings | Required on label | May be in accompanying literature |
| Identity statement | Required on PDP | Required on PDP |
| Adverse event contact | Required on label | Required on label |
Professional Use Limitation
Small Package Exemptions
Products in small containers may qualify for modified labeling requirements:
| Package Size | Exemptions Available | Requirements |
|---|---|---|
| <=0.25 oz / 7g or less | Ingredient declaration exempt | Other requirements still apply |
| <5 sq in total label area | Modified net quantity placement | Still required, flexible location |
| Very small packages | Case-by-case FDA consideration | Contact FDA for guidance |
Common Labeling Mistakes
Avoid These Errors
Common Labeling Mistakes
- Missing or incorrect ingredient order (not by predominance)
- Using trade names instead of INCI names
- Omitting required warnings
- Drug claims without drug labeling
- Missing net quantity or incorrect placement
- No adverse event contact information
- Misleading or unsubstantiated claims
- Incorrect type size for required elements
Label Review Checklist
Complete Cosmetic Label Review
- Statement of identity present on PDP
- Net quantity in correct location with proper type size
- Both metric and US customary units for net quantity
- Name and address of responsible person
- Complete ingredient declaration in proper order
- INCI names used for ingredients
- Required warnings included (if applicable)
- No unsubstantiated or drug claims
- Adverse event contact information present
- Fragrance allergens disclosed (if effective)
- Type is readable and properly sized
- Label information not false or misleading
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