Today, the U.S. Food and Drug Administration announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office of Nonprescription Drugs. The agency is proposing to add bemotrizinol as a permitted active ingredient for use in sunscreens.
Based on the data reviewed by the FDA, bemotrizinol provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin irritation. If this action is finalized, bemotrizinol will be an additional sunscreen active ingredient that the FDA considers to be generally recognized as safe and effective for use by adults and children 6 months of age and older, expanding consumer choice.
“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”
An over-the-counter (OTC) monograph drug, such as a sunscreen product, can enter the market without an approved drug application if it meets certain requirements, including conditions established in its monograph such as permitted active ingredients, uses, and doses. The FDA can modify an OTC monograph through an administrative order (proposed and final), and a drug company may start the process by submitting an OTC Monograph Order Request (OMOR).
Within this context, DSM Nutritional Products LLC submitted a request that the FDA add bemotrizinol, at concentrations up to 6 percent, as a new active ingredient in the OTC monograph for sunscreens. While bemotrizinol has been marketed as a sunscreen ingredient in many countries, the FDA has not previously approved an application for a drug product containing bemotrizinol nor added it to the sunscreen monograph.
The FDA regulates sunscreens to ensure they meet safety and effectiveness standards. Broad spectrum sunscreens that are SPF15 or higher help prevent sunburn and reduce the risks of skin cancer and early skin aging caused by the sun, if products are used as directed with other protective measures, such as wearing protective clothing and limiting time in the sun. Given the recognized public health benefits of sunscreen use, the FDA encourages Americans to use sunscreen with other sun protective measures.
“Bemotrizinol would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers” said Karen Murry, M.D., Acting Director of the Office of Nonprescription Drugs. “The reforms to the monograph drug system contained in the CARES Act have greatly streamlined the monograph drug regulatory process, and we look forward to working with other companies on bringing products containing other new active ingredients to market for a wide array of conditions in multiple therapeutic areas, in a much more timely fashion than was possible in the past.”
The FDA is seeking public comments on this proposed order. Instructions on how to submit comments are in the proposed order available on OTC Monographs@FDA. If FDA concludes bemotrizinol is generally recognized as safe and effective as a sunscreen active ingredient, the agency will issue a final order to add the ingredient to OTC Monograph M020.
Additional information
- For answers to frequently asked questions about OTC monograph drugs and the administrative order process, visit the OTC Monographs @ FDA portal.
- For more information about sunscreens, visit FDA's consumer page on the topic.
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