What Makes a UV Filter 'GRASE' in the FDA's Eyes
The safety bar bemotrizinol just cleared.
Bemotrizinol is the first new active added to the US OTC sunscreen monograph since the 1990s, approved at concentrations up to 6% for adults and children 6 months and older.
Regulatory experts note that because the US treats sunscreens as OTC drugs, a filter must clear a far higher 'GRASE' evidence bar than the cosmetic standard used in the EU or Asia — which is why so few new filters have made it through.
Questions we get a lot
What does GRASE mean for a sunscreen filter?
GRASE stands for 'Generally Recognized As Safe and Effective.' In the US, sunscreens are regulated as OTC drugs, so a UV filter can only be sold under the monograph once the FDA agrees the available data show it is both safe and effective at the proposed use levels — the standard bemotrizinol cleared in 2026.
Which sunscreen filters are approved in the US vs the EU?
The EU has approved 34 UV filters for sunscreens; the US allows about 16 (now 17 with bemotrizinol's 2026 GRASE approval). Filters widely used in Europe and Asia — such as bisoctrizole and drometrizole trisiloxane — remain under FDA review, which is why US options have lagged.
Why does it take so long for the FDA to approve a new sunscreen filter?
Because the US classifies sunscreens as drugs, a new filter needs drug-level safety and effectiveness data to be deemed GRASE — a slow, evidence-heavy process. The EU, Japan and Korea regulate sunscreens as cosmetics or quasi-drugs and can approve modern filters faster, which is why the US monograph stalled for decades before bemotrizinol.
r/SkincareScience: 'What does it actually take for the FDA to call a sunscreen filter GRASE?'