It’s the FDA’s regulatory “rulebook” that defines conditions under which sunscreens are Generally Recognized as Safe and Effective (GRASE) and thus can be marketed without needing an individual New Drug Application (NDA)
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.
SPF measures UVB protection, the rays that cause burns. Higher SPF = stronger protection, but no sunscreen blocks 100% For a more detailed breakdown, refer to this blogpost.
Broad-spectrum means protection from both UVA and UVB. UVA rays cause aging, dark spots, long-term skin damage, whereas UVB rays tend to cause burning.
