What's Happening?
The U.S. Food and Drug Administration (FDA) has announced a proposal to include bemotrizinol as a permitted active ingredient in sunscreens. This initiative is part of a broader effort by the Office of Nonprescription
Drugs to advance sunscreen innovation. Bemotrizinol is known for providing protection against both ultraviolet A and B rays, with minimal skin absorption and low irritation risk. If approved, it will be recognized as safe and effective for use by individuals aged six months and older. The proposal follows a request from DSM Nutritional Products LLC to add bemotrizinol to the over-the-counter (OTC) monograph for sunscreens. The FDA is seeking public comments on this proposed order, which could lead to a final order adding bemotrizinol to the OTC Monograph M020.
Why It's Important?
The inclusion of bemotrizinol in the FDA's list of approved sunscreen ingredients could significantly enhance consumer choice in the U.S. Currently, American consumers have fewer sunscreen options compared to those available internationally. By modernizing the regulation of sunscreen products, the FDA aims to provide timely access to safe and effective over-the-counter products. This move could also encourage other companies to introduce new active ingredients, fostering innovation in the sunscreen market. The potential approval of bemotrizinol aligns with public health goals to reduce skin cancer risks and promote sun safety.
What's Next?
The FDA is currently accepting public comments on the proposed inclusion of bemotrizinol. If the ingredient is deemed safe and effective, the FDA will issue a final order to officially add it to the sunscreen monograph. This process is part of the streamlined regulatory framework established by the CARES Act, which aims to expedite the approval of new OTC drug ingredients. The outcome of this proposal could set a precedent for future additions to the sunscreen ingredient list, potentially leading to a broader range of products available to consumers.
