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Sunscreens

In the European Union, sunscreens are cosmetic products. They are governed by Regulation (EC) No 1223/2009, with authorised UV filters listed in Annex VI and protection performance tested against ISO standards. This contrasts with the United States, where sunscreens are over-the-counter drugs.

Regulatory class

Sunscreens — products applied to the skin with the principal function of protecting it from ultraviolet (UV) radiation — fall within the definition of "cosmetic product" in Article 2 of Regulation (EC) No 1223/2009, in particular in the function "protecting the skin in good condition". They are therefore subject to the general regime of the Cosmetic Regulation, including the safety assessment, the responsible person, the CPNP notification and the substance Annexes.

Authorised UV filters

Annex VI of Regulation 1223/2009 sets out the list of UV filters that may be used in EU cosmetic products. Each entry specifies the substance, its INCI name, the maximum concentration permitted in the finished product, and any other conditions of use (for example, restrictions on aerosol or spray formats for nanomaterial filters). The Annex is updated by Commission regulation as the science evolves, on the basis of SCCS opinions. Examples of authorised filter classes include cinnamates, salicylates, benzophenones, dibenzoylmethanes, triazines and the inorganic filters zinc oxide and titanium dioxide; the EUR-Lex consolidated text is the operational reference for the current entries and their conditions.

Substances not listed in Annex VI cannot be used in EU cosmetics as UV filters. This is a closed-list system: any new UV filter must go through an SCCS opinion and a Commission amendment of Annex VI before it can lawfully be used in finished products on the EU market.

Mineral vs. organic filters

Cosmetic literature distinguishes two broad classes of UV filter: mineral (inorganic) filters — zinc oxide and titanium dioxide — and organic filters (small-molecule organic compounds that absorb UV radiation). Both classes appear in Annex VI of the Regulation and both may be used in EU sunscreens, including in combination. The choice between them is a question of formulation and aesthetics: mineral filters tend to leave a more visible white residue on the skin (a "cast") unless the particle size is reduced or modified, while organic filters typically produce a cosmetically lighter feel but can have specific stability and tolerance characteristics.

Marketing terminology such as "physical" versus "chemical" filters is widely used; the physico-chemical reality is that all UV filters attenuate UV by some combination of absorption and scattering, and the binary terminology should not be over-interpreted.

SPF and UVA-PF testing

The Sun Protection Factor (SPF) is the standard measure of protection against UVB-induced erythema. It is determined by the in-vivo method specified in ISO 24444, which involves measuring the minimum erythemal dose (MED) on protected and unprotected skin on volunteer subjects.

UVA protection is measured by the UVA-PF (UVA Protection Factor) using the in-vitro method specified in ISO 24443, which characterises the UVA transmission of the sunscreen film on a defined substrate. The European Commission Recommendation 2006/647/EC sets out the labelling requirement that the UVA-PF be at least one-third of the labelled SPF; products meeting this ratio may carry the "UVA" symbol (the letters UVA in a circle), often referred to as the "UVA seal" or "EU UVA logo".

Labelling and the UVA seal

European Commission Recommendation 2006/647/EC, on the efficacy of sunscreen products and the claims made relating thereto, sets common rules for labelling. The principal labelled categories are Low protection (SPF 6 to 10), Medium (15 to 25), High (30 to 50), and Very high (50+). Numerical SPF values higher than 50 are not labelled as a specific number above 50: the recognised maximum on labels is "50+".

The UVA seal indicates that the product meets the UVA-PF ≥ SPF/3 ratio criterion. EU sunscreens commonly carry both an SPF value and the UVA seal; the absence of the UVA seal is itself information.

EU vs. US regulation

Sunscreen regulation in the United States is fundamentally different. In the US, sunscreens are regulated as over-the-counter drugs by the Food and Drug Administration under a monograph system. The list of "GRASE" (generally recognised as safe and effective) active ingredients in the US is shorter than the EU Annex VI list, and several modern UV filters routinely used in EU sunscreens are not yet available in US products. The labelling, testing and claims rules also differ. A sunscreen that is legally on the EU market is not, by that fact, legally on the US market, and vice versa.

What to look for on a label

For a consumer looking at an EU sunscreen label, the readily-interpretable indications are: the SPF (labelled category and number), the presence or absence of the UVA seal, the listed UV filters (in the INCI ingredients list, in conformity with cosmetic labelling rules), and any specific intended-use information such as "water-resistant" (with the corresponding testing standard) and the period-after-opening symbol. This site does not provide product recommendations and does not interpret labels as a basis for purchasing decisions; the information above is provided as a label-literacy reference.

Last reviewed: May 2026.