U.S. FDA Proposes Bemotrizinol as a New Sunscreen Ingredient to Expand Consumer Choices

The U.S. Food and Drug Administration (FDA) has announced a proposal to include bemotrizinol as a permitted active ingredient in sunscreens, advancing innovation in over-the-counter (OTC) drug products. Bemotrizinol provides broad-spectrum protection against both UVA and UVB rays, exhibits minimal skin absorption, and rarely causes irritation. If approved, it would be recognized as safe and effective for adults and children aged six months and older, expanding consumer options. FDA Commissioner Marty Makary emphasized the agency’s efforts to modernize sunscreen regulations, addressing the historical lag that limited American consumers’ choices compared to international markets. The FDA regulates OTC sunscreens under monographs, which allow products meeting specified standards to enter the market without individual approvals. Companies can propose additions via an OTC Monograph Order Request (OMOR). DSM Nutritional Products LLC requested the addition of bemotrizinol at concentrations up to 6 percent. While used internationally, it has not yet been approved in the U.S. The FDA encourages sunscreen use alongside protective measures to reduce sunburn, skin cancer, and premature aging. Public comments on the proposal are invited before a final order is issued.