Homosalate
Description
Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester
Function
Properties
Regulatory Status
UVB filter with declining regulatory standing in both EU and US. EU SCCS 2021 endocrine disruption concern triggered restriction from 10% to 7.34% in face products only, effective January 2025 with product withdrawals by July 2025. US permits up to 15% but FDA maintains regulatory limbo status with final GRASE determination pending. Systemic absorption confirmed in FDA PK studies. Not a primary performance filter due to UVB-only spectrum and limited coverage. Increasing restriction in EU and unresolved FDA status make homosalate a higher-risk choice for new formulation development.
Historically marketed in the US; FDA states existing data is not sufficient to determine GRASE. Regulatory limbo alongside seven other chemical filters. Final determination pending additional safety data. Previously permitted up to 15% in the US monograph.