US Cosmetic Label Review (MoCRA & FDA)
A detailed review of your cosmetic label against FDA labelling rules, the FPLA and MoCRA.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
US cosmetic labels must meet FDA's labelling regulations, the Fair Packaging and Labeling Act and MoCRA, which adds a US contact for adverse event reports. We review the identity statement, net quantity, ingredient list, responsible person details, warnings and claims, and flag any drug claims. £595 per product.
What's included in your label review
| Document | What it is |
|---|---|
| Principal display panel | Statement of identity and net quantity in US units |
| Ingredient declaration | Order and naming checked against 21 CFR 701.3 |
| MoCRA contact | Responsible person name and US contact for adverse event reports |
| Warnings | Required warning statements for your product type |
| Claims review | Claims that could make the product a drug flagged |
Who this label review is for
- UK and EU brands adapting labels for the US
- Amazon US sellers asked to fix labelling
- Brands launching new US products
What this label review does not include
- Label design. We review and mark up; artwork changes are yours or a separate service.
- OTC drug labels. Sunscreens and other OTC drugs need a Drug Facts review.
- State-law labelling. Some states have their own rules; we flag known issues but do not do a full state review.
- Several products. Each product label is reviewed separately.
How it works
- Send your label Artwork or photos of every panel, with the formula.
- Review We check each element against FDA, FPLA and MoCRA rules.
- Report You receive a marked-up report with required changes.
- Recheck One recheck of the revised label is included.
What does a US cosmetic label need?
US cosmetic labels are governed by FDA's cosmetic labelling regulations (21 CFR Part 701 and 740), the Fair Packaging and Labeling Act (FPLA) and MoCRA. They need a statement of identity, net quantity in US units, an ingredient declaration in the required order, the name and place of business of the manufacturer, packer or distributor, and, under MoCRA section 609, a domestic US contact for adverse event reports. Claims that a product treats or prevents disease, or affects the body's structure or function, may make it a drug.
What we check
Required elements:
- Identity and net quantity on the principal display panel.
- Ingredients in descending order of predominance.
- Responsible person and US contact.
- Warnings such as for aerosols or specific product types.
Watch items (status at order):
- Fragrance allergens: FDA has not yet proposed the MoCRA fragrance allergen labelling rule; the statutory deadline has passed and FDA's agenda lists a proposal for late 2026.
- Talc: FDA's 2024 proposed talc asbestos-testing rule was withdrawn in November 2025; a new proposal is expected but not yet published.
- PFAS: FDA's December 2025 PFAS report found the data insufficient for a full safety assessment; there is no federal PFAS ban in cosmetics, but some US states have their own laws.
What you receive
- Marked-up label review report
- A list of required and recommended changes
- One recheck of the revised label
Legal framework
- 21 CFR Part 701 — cosmetic labelling, including ingredient declaration (701.3)
- 21 CFR Part 740 — cosmetic warning statements
- Fair Packaging and Labeling Act — identity and net quantity
- FD&C Act section 609 — MoCRA label contact for adverse events
- FD&C Act section 201(g) — drug definition and claims
Official sources:
Why brands choose Phoenix
- Every panel reviewed — not just the ingredient list.
- Drug-claim risks flagged.
- Recheck included.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Fix your label before you print. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
What must a US cosmetic label include?
A statement of identity, net quantity, ingredient declaration, the name and place of business of the manufacturer, packer or distributor, any required warnings and, under MoCRA, a US contact for adverse event reports.
Can I use my EU label in the US?
Usually not without changes. Net quantity units, ingredient naming and the US contact often differ.
Do US labels need fragrance allergens listed?
Not yet. FDA has not yet proposed the MoCRA fragrance allergen labelling rule; the statutory deadline has passed and FDA's agenda lists a proposal for late 2026.
What claims make a cosmetic a drug?
Claims to treat or prevent disease or to affect the structure or function of the body, such as 'anti-acne' or 'hair regrowth', can make a product a drug.
Is a recheck included?
Yes. One recheck of your revised label is included.
How much does the label review cost?
£595 per product label.