UV Filters
Substances used in cosmetic products to absorb, reflect, or scatter ultraviolet radiation to protect the skin or hair. UV filters are regulated under positive lists: EU Annex VI permits 28 UV filters; the US classifies sunscreens as OTC drugs regulated under FDA monographs rather than as cosmetics.
UV filters are active substances used in sunscreens and other cosmetic products to protect the skin from the harmful effects of ultraviolet radiation. They are among the most heavily regulated cosmetic ingredients globally, with significant differences in regulatory approach between jurisdictions.
In the EU, UV filters are regulated as cosmetic ingredients under Annex VI of EC 1223/2009, which maintains a positive list of 28 permitted UV filters with maximum authorized concentrations and specific conditions of use. Only UV filters listed in Annex VI may be used in cosmetic products for the purpose of UV protection. The SCCS evaluates the safety of UV filter substances and provides opinions that inform additions or amendments to Annex VI.
In the US, sunscreen products are classified as over-the-counter (OTC) drugs, not cosmetics. UV filter ingredients are regulated under the FDA's OTC Monograph system (21 CFR Part 352). Only 16 UV filters are currently permitted in US sunscreens, and the FDA has requested additional safety data for 12 of these under the CARES Act sunscreen reform provisions. Only zinc oxide and titanium dioxide are currently classified as GRASE (Generally Recognized as Safe and Effective) by the FDA.
This regulatory divergence is one of the most significant cross-market compliance challenges in cosmetics. Several UV filters widely used in EU and Asian sunscreens (including Tinosorb S, Tinosorb M, Mexoryl SX, and Mexoryl XL) are not available in the US. Brands formulating for multiple markets must maintain separate sunscreen formulations for the US and EU.
Related Terms
EU Cosmetics Regulation (EC 1223/2009)
The primary European Union law governing cosmetic products, establishing requirements for safety assessment, CPNP notification, responsible person designation, ingredient restrictions (Annexes II-VI), labeling, and post-market surveillance across all EU/EEA member states.
IngredientAnnex III — EU Restricted Substances List
The list of substances restricted to specific conditions of use in cosmetic products under EC 1223/2009. Annex III specifies maximum concentrations, product types, warnings, and other conditions under which listed substances may be used.
OrganizationScientific Committee on Consumer Safety (SCCS)
An independent scientific committee that advises the European Commission on health and safety risks of non-food consumer products, including cosmetic ingredients. SCCS opinions form the scientific basis for EU ingredient restrictions in the Cosmetics Regulation annexes.
OrganizationFood and Drug Administration (FDA)
The US federal agency within the Department of Health and Human Services responsible for regulating cosmetics, food, drugs, medical devices, and other products. Under MoCRA, the FDA has expanded authority over cosmetics including facility registration, product listing, and mandatory recall power.
Regulation21 CFR Part 700
The section of the US Code of Federal Regulations containing FDA regulations specific to cosmetic products, including prohibited ingredients, required warning statements, and labeling requirements. Parts 700-740 collectively govern cosmetics.
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