FDA Approves Bemotrizinol: A Breakthrough in Sunscreen Technology
The U.S. Food and Drug Administration has recently approved a new sunscreen active ingredient, bemotrizinol, marking the first addition to the list of permitted over-the-counter sunscreen ingredients in over two decades. Bemotrizinol offers protection against both UVA and UVB rays with minimal absorption into the body through the skin. The FDA deems bemotrizinol safe and effective for use in sunscreens for individuals aged 6 months and older. This ingredient has been utilized in sunscreens in Europe and other countries for several years.
DSM Nutritional Products LLC submitted a request to include bemotrizinol as an active ingredient in OTC sunscreens at concentrations up to 6%. The FDA issued a proposed order in December 2025 and finalized its decision after reviewing public comments. This change aims to broaden sunscreen options and encourage innovation in the sunscreen industry. Sunscreen products can be introduced to the market without a drug application if they comply with the FDA's OTC monograph requirements, including approved active ingredients, uses, and doses.
In conclusion, the approval of bemotrizinol as a new sunscreen active ingredient by the FDA signifies a significant advancement in sunscreen technology and provides consumers with additional options for sun protection.