A sunscreen manufactured in Europe cannot automatically be placed on the US market. In the United States, sunscreens follow an OTC drug framework and need a dedicated route.
Why this matters in a sunscreen project
A responsible brief aligns performance, user experience, manufacturing, packaging, documentation and market requirements. Commercial statements should only be finalised when the evidence matches the finished product.
A different regulatory architecture
UV filters available in Europe may not match actives permitted in the USA. Market strategy should be set before formula completion.
Monograph compliance
Actives, concentrations, Drug Facts labelling, tests and manufacturing should be reviewed against the current OTC monograph and related duties.
Supply-chain responsibilities
Brand, manufacturer, importer and US partners must define registration, listing, quality, distribution and surveillance roles as applicable.
One concept, adapted formulas
Some projects explore EU and US versions with shared sensory positioning while using compositions and files suited to each market.
Briefing checklist
- US classification and claims
- Permitted actives
- Current monograph
- Drug Facts label
- Testing and local responsibilities
Frequently asked questions
Can an EU SPF 50 formula be sold unchanged in the USA?
That should not be assumed; actives, categories, tests and labelling can differ.
Does CPNP apply in the USA?
No. CPNP belongs to the EU cosmetics framework.
Can it still be manufactured in Spain?
Yes, provided the product and supply chain meet applicable US requirements.
Development and manufacturing with OKT GLOBAL
OKT GLOBAL integrates R&D, quality, regulatory support, packaging, scale-up and manufacturing in Spain under UNE-EN ISO 22716 certified by Bureau Veritas.