Why Labeling Is Your First Line of Defense
A compliant label is not just a legal requirement — it is a signal of product integrity to regulators, retailers, and consumers. Both FDA and Health Canada have detailed rules about what must appear on a cosmetic label, and the rules are not identical.
FDA Cosmetic Labeling Requirements (21 CFR Part 701)
Principal Display Panel (PDP)
The PDP must include:
- Identity of the product (e.g., "Moisturizing Lotion")
- Net quantity of contents (weight, measure, or count) in both metric and U.S. customary units
Information Panel
The information panel must include:
- Name and address of the manufacturer, packer, or distributor
- Ingredient declaration in descending order of predominance (INCI names required)
- Warnings where required (e.g., for aerosol products, flammable ingredients)
MoCRA Updates to Labeling
Under MoCRA, FDA may now require:
- Disclosure of fragrance allergens (rulemaking in progress)
- Responsible Person contact information on label or via website/QR code link (for AE reporting)
Health Canada Cosmetic Labeling Requirements
Bilingual Obligation
All cosmetics sold in Canada must have labels in both English and French. This includes:
- Product identity
- Net quantity
- Warnings and cautions
- Directions for use (where applicable)
Ingredient Declaration (INCI)
Health Canada requires INCI ingredient names in descending order, consistent with FDA. However, the bilingual requirement does not apply to INCI ingredient names — these may appear in INCI format only (Latin/English).
Mandatory Elements
- Product identity (bilingual)
- Net quantity (metric units required; dual declaration optional)
- Name and address of the Canadian Responsible Person
- Any required warnings in both languages
Key Differences at a Glance
| Element | FDA (U.S.) | Health Canada (Canada) | |---|---|---| | Language | English | English + French (bilingual) | | Net quantity | U.S. + metric | Metric required | | INCI names | Yes, descending order | Yes, descending order | | Responsible Person info | Required (post-MoCRA) | Required | | Warning language | English | English + French |
Common Labeling Violations
- Font size too small — FDA requires minimum 1/16 inch for ingredient declarations
- Missing net quantity or metric unit omission for Canadian market
- French translation missing on Canadian labels
- INCI names incorrect — using trade names instead of INCI names
- Claims that trigger drug classification (e.g., "reduces acne" without OTC drug registration)
How United Regulatory Can Help
We review cosmetic labels for both FDA and Health Canada compliance — ingredient declarations, bilingual formatting, warning statements, and MoCRA updates. Contact us before printing your next label run.