FDA Proposes Approving New Sunscreen Ingredient

The U.S. Food and Drug Administration has announced a proposal to expand the list of active ingredients permitted for use in sunscreens, a move that could offer consumers more choices for sun protection. This proposed action, part of the agency’s ongoing efforts to modernize the regulation of over-the-counter drug products, specifically seeks to add bemotrizinol to the list of ingredients generally recognized as safe and effective for use in sunscreens.

According to the FDA, bemotrizinol has demonstrated effectiveness in protecting against both ultraviolet A and B rays. Data reviewed by the agency indicates that this ingredient has low absorption rates through the skin and is rarely associated with skin irritation. If finalized, bemotrizinol would be available for use in sunscreen products for both adults and children aged six months and older, potentially broadening the range of consumer-friendly options on the market. The FDA regulates sunscreens to ensure they meet established safety and effectiveness standards. Products that offer broad-spectrum protection with an SPF of 15 or higher, when used as directed alongside other protective measures like protective clothing and limiting sun exposure, can help prevent sunburn and reduce the risks of skin cancer and premature skin aging.

The addition of bemotrizinol stems from a request submitted by DSM Nutritional Products LLC, which proposed its inclusion at concentrations up to 6 percent. While bemotrizinol is already used in sunscreen formulations in numerous other countries, it has not previously been approved by the FDA for such use or added to the U.S. sunscreen monograph. The FDA regulates over-the-counter (OTC) monograph drugs, like sunscreens, allowing them to enter the market without a formal drug application if they meet specific monograph conditions, including permitted ingredients, uses, and dosages. The agency can amend these OTC monographs through an administrative order process, which can be initiated by companies submitting an OTC Monograph Order Request (OMOR).

The FDA is currently seeking public commentary on this proposed order. Interested parties can find instructions for submitting comments within the proposed order, which is accessible on the OTC Monographs@FDA portal. Should the FDA determine that bemotrizinol is indeed generally recognized as safe and effective for sunscreen use, the agency will issue a final order to incorporate it into OTC Monograph M020. This initiative reflects the agency’s commitment to facilitating timely access to innovative and effective over-the-counter products for the American public.

Article by Mel Anara, based upon information from the U.S. Food and Drug Administration

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