U.S.–EU UV-Filter Reference
Compare sunscreen active ingredients listed in the current U.S. OTC Monograph M020 with UV filters authorised under Annex VI of the EU Cosmetics Regulation. Review maximum concentrations, key conditions, shared-filter directions, and the limits of using a numerical comparison for cross-market development.
Last reviewed: July 20, 2026
This reference is for B2B formulation and market-route screening. It does not establish finished-product compliance or replace review of the exact formula, material grade, testing, labeling, manufacturing route, and destination market.
Read the Status First
The United States and European Union regulate sunscreen through different routes. In the United States, sunscreen generally follows an over-the-counter drug framework. In the European Union, sunscreen is regulated as a cosmetic product, with UV filters controlled through Annex VI of Regulation (EC) No 1223/2009.
The tables below use three distinctions:
Names are mapped where the U.S. established name and EU INCI or glossary name differ. The same-sounding commercial name should never be treated as proof that two materials are identical.
United States
The following 16 ingredients and maximum concentrations appear in the currently effective M020 text used for this review. A listed maximum is only one monograph condition. Permitted combinations, contribution to finished-product SPF, dosage form, testing, Drug Facts labeling, manufacturing controls, establishment or product listing obligations, and other applicable requirements still need review.
| FDA established name | Common INCI or synonym | Maximum concentration | Status and key note |
|---|---|---|---|
| Aminobenzoic acid (PABA) | PABA | 15% | Effectivecombination rules apply |
| Avobenzone | Butyl Methoxydibenzoylmethane | 3% | Effectivecombination rules apply |
| Cinoxate | Cinoxate | 3% | Effectivenot listed as an EU Annex VI filter |
| Dioxybenzone | Benzophenone-8 | 3% | Effectivenot listed as an EU Annex VI filter |
| Ensulizole | Phenylbenzimidazole Sulfonic Acid | 4% | Effective |
| Homosalate | Homosalate | 15% | EffectiveEU scope is substantially narrower |
| Meradimate | Menthyl Anthranilate | 5% | Effectivenot listed as an EU Annex VI filter |
| Octinoxate | Ethylhexyl Methoxycinnamate; formerly Octyl Methoxycinnamate | 7.5% | Effective |
| Octisalate | Ethylhexyl Salicylate; formerly Octyl Salicylate | 5% | Effectivenot listed as an EU Annex VI filter |
| Octocrylene | Octocrylene | 10% | Effectivecombination rules apply |
| Oxybenzone | Benzophenone-3 | 6% | EffectiveEU limit depends on product type |
| Padimate O | Ethylhexyl Dimethyl PABA | 8% | Effective |
| Sulisobenzone | Benzophenone-4 | 10% | EffectiveEU entry also covers the sodium salt and uses an acid-equivalent limit |
| Titanium dioxide | Titanium Dioxide | 25% | Effectiveexact material and dosage form require review |
| Trolamine salicylate | TEA-Salicylate | 12% | Effectivenot listed as an EU Annex VI filter |
| Zinc oxide | Zinc Oxide | 25% | Effectiveexact material and dosage form require review |
Status watch
FDA issued Final Administrative Order OTC000039 to add Bemotrizinol at up to 6% to M020. The order states an effective date of August 9, 2026, unless disputed under the applicable process. Because this page was reviewed on July 20, 2026, Bemotrizinol is not included in the currently effective U.S. table above.
The final order also includes conditions for finished-product SPF, combinations, dosage forms, and an 18-month exclusivity provision tied to the requestor and qualifying licensees, assignees, or successors. It does not mean that every manufacturer or formula may use Bemotrizinol in the United States from the date the order was issued.
Recheck the FDA OTC Monographs portal on or after August 9, 2026 before changing this status. For ingredient-specific development context, review Bemotrizinol sunscreen formulation considerations .
Interpret the Numbers Carefully
A regulatory maximum is a ceiling under specified conditions, not a required or preferred use level. A higher percentage does not automatically deliver a higher SPF. Finished-product performance depends on the complete filter system, dispersion, solubility, photostability, film formation, application amount, vehicle, packaging, and test result.
Use these distinctions throughout project planning:
Permitted ingredient ≠ Approved finished product
Maximum concentration ≠ Recommended use level
Shared numerical limit ≠ Cross-market compliance
Supplier data ≠ Finished-product SPF evidence
The lower U.S. or EU number is useful for initial screening only. It does not settle active-ingredient combinations, nano status, dosage form, spray exposure, face or body scope, raw-material composition, stability, labeling, or responsible-party obligations.
From List to Brief
A useful sunscreen brief should identify the target market, face or body use, product format, intended SPF and UVA direction, tinted or non-tinted positioning, preferred filter system, reference product, packaging, and testing scope.
The formulation review should then consider:
Do not use this page as a ready-made UV-filter formula. Move the selected direction into Sunscreen Development and Formula Development for project assessment.
Ingredient Eligibility Is Only One Layer
United States
A U.S. project may require review of OTC drug classification, monograph conformity, permitted active combinations, dosage form, finished-product SPF and broad-spectrum testing, water-resistance testing when claimed, drug cGMP, establishment and product listing requirements, Drug Facts labeling, and other applicable controls.
European Union
An EU project may require a Responsible Person, Cosmetic Product Safety Report, Product Information File, CPNP notification, GMP, claims substantiation, SPF and UVA testing, labeling, and nanomaterial obligations where applicable.
Rixin can discuss formulation, packaging, testing, and documentation requirements against a defined project brief. This does not guarantee registration, listing, notification, authorisation, or market access. Review Quality, Testing & Documentation before finalising the development route.
Source and Maintenance Discipline
This page is based on the following official materials:
No. Shared ingredient identity and a shared numerical ceiling do not resolve combinations, material form, finished-product testing, manufacturing, labeling, documentation, notification, listing, or other market requirements.
No. It is an initial screening ceiling. Product-specific restrictions, combined-use limits, nano status, impurity requirements, and the complete formula may create additional constraints.
Annex VI may apply different material specifications and inhalation restrictions to nano forms. The supplier material and particle characteristics must match the relevant entry.
Not on this page’s July 20, 2026 review date. FDA’s final order states an effective date of August 9, 2026 unless disputed. Its status, conditions, and exclusivity provisions must be rechecked before use in a U.S. project.
Provide the intended markets, product format, face or body use, SPF and UVA direction, preferred filters, formula status, tint and sensory targets, packaging, testing needs, documentation scope, quantity, and launch timing.
Prepare the Exact Brief
Share the intended U.S., EU, or dual-market route, product format, face or body use, SPF and UVA direction, preferred filters, formula status, packaging, quantity, testing, documentation, and launch timing. Rixin will review the brief and discuss the next suitable development step.