UV filters in the EU vs the US: what each market allows
The EU allows modern organic filters such as Bemotrizinol (Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine) at 10% (Annex VI No 25) — filters the FDA has not approved for the US. US sunscreens must use FDA-approved active ingredients and are drugs; EU sunscreens are cosmetics.
Short answer: the same "sunscreen" is a different product in each market. In the EU, sunscreens are cosmetics using filters from Annex VI of Regulation 1223/2009 — including modern broad-spectrum filters like Bemotrizinol, capped at 10% (Annex VI No 25). In the US, sunscreen active ingredients are OTC drugs regulated by the FDA, and the approved list is shorter — several of the EU's modern filters are not on it.
The numbers
| Filter | EU status | US status |
|---|---|---|
| Bemotrizinol (Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine) | Annex VI No 25, ≤ 10% | Not FDA-approved |
| Polysilicone-15 | Annex VI No 26, ≤ 10% | Not FDA-approved |
| Titanium Dioxide | Annex VI No 27, ≤ 25%, powder-size conditions; “(nano)” form has its own conditions | FDA-approved active |
| Avobenzone | In Annex VI with its own conditions | FDA-approved active |
The headline numbers above are from the EU consolidated text (18.05.2026). The US list of approved sunscreen actives and the FDA's regulatory route for them are stated on FDA's sunscreen pages — check the current list there before buying raw materials, because it changes through rulemaking, not yearly.
US vs EU
Two consequences trip up US brands selling into the EU:
- A US "SPF 30" formula is a drug in the US but a cosmetic in the EU — different paperwork, different labeling regime (Drug Facts vs cosmetic ingredient list).
- The filter you bought may not exist in the other market's list. Bemotrizinol is everywhere in EU sunscreens and absent from US ones. An SPF claim itself makes a US product a drug; in the EU it stays a cosmetic with a filter cap from Annex VI.
Common mistakes
- Shipping a US sunscreen to the EU and assuming the label works. Different regime, different filter rules, different warnings.
- Making an SPF claim on a US moisturizer without treating it as an OTC drug.
- Buying a filter because "it's allowed in the EU" and using it in the US — the US list, not the EU list, governs there.
Do this now
Split your formula's filter list by market: every filter gets tagged "EU Annex VI (with entry number)" or "US FDA-approved". A filter with only one tag can only ship to one market.
FAQ
Is Bemotrizinol allowed in US sunscreens?
No. It is an EU filter (Annex VI No 25, up to 10%) but not FDA-approved for the US.
Are sunscreens cosmetics in the EU?
Yes. EU sunscreens are cosmetics using filters from Annex VI of Regulation 1223/2009; US sunscreens are OTC drugs.
Is titanium dioxide allowed in both markets?
Yes, but with different rules: the EU caps it at 25% with powder-form conditions (Annex VI No 27), and the US treats it as an FDA-approved active.
Sources
- Regulation (EC) No 1223/2009, Annex VI No 25, No 26, No 27 — consolidated text 18.05.2026
- FDA, sunscreen drug products and approved active ingredients — fda.gov
- FD&C Act §201(g) — SPF claims make the product a drug in the US — fda.gov, “Is It a Cosmetic, a Drug, or Both?”
Last verified: 2026-11-10. EU figures were checked against the consolidated text; the current US approved list is on the FDA page above and should be re-checked there.
Not legal advice, and not a guarantee of compliance or of acceptance by any authority.
Want this checked against your own formula? Run the free label check. It flags SPF claims that make a US product a drug and checks EU filter limits. It returns an issue list, not a print-ready label.
Related: SPF claims make it a drug · Nano labeling on EU labels