US Market Entry: Labelling & Claims
US cosmetic labelling is permissive on format and strict on accuracy: the ingredient declaration must appear in descending order using INCI names, the responsible business must be identified, and net content must be declared. A therapeutic claim moves the product to drug labelling.
At a glance
- Ingredient declaration
- INCI names, descending order of concentration
- Business identity
- Name and address of the responsible business
- Net content
- Metric with US customary units
- Period-after-opening symbol
- Not required, unlike the EU
What the market requires
Ingredient declaration
Ingredients are declared in descending order of concentration using INCI names, with colour additives handled separately. Trade-secret protection exists, but it requires a specific filing rather than being automatic.
Identity, content and warnings
The label identifies the responsible business, states net content and carries any warnings the product needs. US rules do not require the EU's period-after-opening symbol, so European artwork cannot simply be reused.
Claims and the drug boundary
A claim that the product treats or prevents a condition takes it out of cosmetics. Sunscreen is the common example and is sold under OTC drug labelling with a drug facts panel and permitted monograph actives.
What this means for your brief
Label copy should be settled against the claim you intend rather than the reverse. If a marketing sentence implies treatment, the artwork changes and so does the testing set, which is why claim review belongs before design rather than after.
What we provide
- Ingredient declarations produced from the formula in descending INCI order
- Label content prepared for your compliance review before anything is printed
- Documentation behind the claims that the formula and testing can actually support
Capabilities above are limited to what is verifiable: GMPC and ISO 22716 certification audited by third parties, cosmetics production licence 粤妆20250206, and FDA MoCRA facility registration. See certifications.
Market questions
Can I use an EU label in the US?
Not as-is. The US does not require the PAO symbol, uses different net content conventions, and applies drug rules to products such as sunscreen. The two markets need separate artwork.
Do sunscreens follow cosmetic labelling?
No. Sunscreen is regulated as an over-the-counter drug in the US, so it carries a drug facts panel and must use actives permitted by the OTC monograph.
More on United States market entry
Regulatory requirements change. Confirm the current position for your product with your local adviser or appointed representative before you place artwork or place an order. See also certifications and compliance and the sourcing glossary.
Sourcing for United States?
Send your product brief with the destination market — quotation and formula recommendations within 24 hours.
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