The agency is seeking public comment on a proposal to classify bemotrizinol as generally recognized as safe and effective for over-the-counter sunscreens.
The US Food and Drug Administration (FDA) has proposed adding bemotrizinol to the list of permitted active ingredients for over-the-counter sunscreens, a move the American Academy of Dermatology Association says could expand protection options for patients and bring US sunscreen regulation closer in line with other countries.
In an announcement released Dec 11, the FDA says it is proposing to classify bemotrizinol as generally recognized as safe and effective (GRASE) for use in sunscreens for adults and children 6 months of age and older. If finalized, the ingredient would be added to the agency’s sunscreen monograph, allowing manufacturers to market products containing bemotrizinol without submitting a new drug application, provided other monograph requirements are met.
Bemotrizinol is a broad-spectrum ultraviolet filter that provides protection against both UVA and UVB radiation. According to the FDA, the data reviewed show low levels of systemic absorption through the skin and a low likelihood of skin irritation. The ingredient has been used in sunscreen formulations in many countries for years but has not previously been permitted for use in US over-the-counter sunscreens.
FDA commissioner Marty Makary, MD, MPH, framed the proposal as part of a broader effort to modernize regulation of nonprescription drugs. “The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad,” Makary said in the release. “We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products.”
The proposal stems from a request submitted by DSM Nutritional Products LLC through the FDA’s OTC Monograph Order Request process, which was restructured under the CARES Act to allow for administrative updates to monographs rather than requiring full rulemaking. DSM requested that bemotrizinol be permitted at concentrations up to 6%.
Potentially Expanding Sunscreen Formulation Options
For dermatologists and plastic surgeons, the announcement touches on long-standing concerns about limited sunscreen formulation options in the US, particularly when counseling patients on photoprotection after procedures or for long-term skin cancer prevention. The American Academy of Dermatology Association welcomed the FDA’s action, noting that it is the first proposed addition of a new sunscreen active ingredient in more than two decades.
“The American Academy of Dermatology Association applauds the Food and Drug Administration for taking the first steps in more than two decades to provide more safe and effective sunscreen options to the American public,” says Susan C. Taylor, MD, FAAD, president of the AAD, in a statement.
The academy emphasizes the public health implications of broader sunscreen access, citing the prevalence of skin cancer in the United States. Unprotected ultraviolet exposure remains a major risk factor, with an estimated one in five Americans developing skin cancer during their lifetime and nearly 20 melanoma-related deaths occurring each day.
Dermatologists routinely see the downstream effects of UV damage, including skin cancer, photoaging, and complications that can affect both medical and aesthetic outcomes. The academy reiterates its guidance that patients use a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher on exposed skin, in addition to seeking shade and wearing protective clothing.
The FDA also underscored the role of sunscreen as part of a broader sun-protection strategy, noting that broad-spectrum products with SPF 15 or higher can help prevent sunburn and reduce the risk of skin cancer and early skin aging when used as directed.
Public Comments Being Accepted
While the proposal does not immediately change what products are available on the market, it opens the door for manufacturers to develop new formulations once a final order is issued. The FDA is currently seeking public comment on the proposed order before making a final determination on bemotrizinol’s GRASE status.
If finalized, the addition would modestly narrow the gap between the US and other countries, many of which have approved significantly more UV filters for consumer use. The academy has long advocated for expanding sunscreen options domestically, citing both patient adherence and formulation flexibility as ongoing challenges.
Public comments on the proposed order will be accepted through the FDA’s OTC Monographs@FDA portal before the agency issues a final decision.
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