The main differences between U.S. and European sunscreens come down to regulation, ingredients, UVA protection standards, and SPF labeling.
Regulatory Path:
-US: Sunscreens are regulated as over-the-counter (OTC) drugs under the FDA’s sunscreen monograph. Any new UV filter must go through a full drug approval process, which is lengthy and expensive.
-EU: Sunscreens are regulated as cosmetics. New UV filters can be approved through the EU Cosmetics Regulation, a faster and more flexible process.
Available UV Filters:
-US: Only 16 active ingredients are permitted under the FDA monograph, and most are decades old. The only FDA-recognized GRASE (safe/effective) ones under the proposed order are zinc oxide and titanium dioxide.
-EU: More than 30 filters are approved, including newer and more stable UVA filters such as Tinosorb S, Tinosorb M, Uvinul A Plus, Mexoryl SX/XL. These provide stronger, longer-lasting UVA coverage.
UVA Standards:
-US: Broad-spectrum labeling requires only that UVA protection is proportional to UVB (SPF) protection, with a relatively low bar. Products can legally have high SPF but weak UVA protection.
-EU: The UVA-PF (protection factor) must be at least 1/3 of the SPF, ensuring better UVA balance. EU sunscreens are generally stronger against UVA (linked to aging, pigmentation, and skin cancer risk).
SPF labeling
-US: No cap on SPF claims under the current rule (though FDA has proposed max “60+”). This allows very high SPF labeling (like SPF 100).
-EU: SPF values are capped at 50+, since higher numbers don’t provide meaningful extra protection and can mislead consumers.
