The US Food and Drug Administration announced a proposed order today that would add bemotrizinol to the list of permitted sunscreen active ingredients. The proposal is part of FDA’s ongoing effort within the Office of Nonprescription Drugs to modernize the OTC monograph system and expand consumer access to effective UV filters.
FDA details proposed addition
In its announcement, the agency stated that bemotrizinol offers broad-spectrum protection and shows low systemic absorption in available data.
“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, MD, MPH. “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”
According to FDA, bemotrizinol rarely causes irritation and would be considered generally recognized as safe and effective for adults and children over six months if the order is finalized. The request to add the ingredient was submitted by DSM Nutritional Products LLC at concentrations up to six percent, as previously reported by CDU in October.
“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,” she added.
A public comment period on the proposal is currently open, and if FDA determines that bemotrizinol meets GRASE criteria, it will be added to OTC Monograph M020.
The US Department of Health and Human Services (HHS) echoed the announcement, noting in a press release that the ingredient’s potential role within established public-health goals. HHS highlighted that the proposal fits within federal efforts to support products that reduce the risks of sunburn, skin cancer and early skin aging when used as directed.
Dermatology expert reacts
Clinical and cosmetic dermatologist Jane Yoo, MD, MPP, told CDU the proposal holds relevance for patient populations where UVA stability is critical. “Clinically, the strongest impact of a filter like bemotrizinol is on UVA protection,” Dr. Yoo said.
“High, stable UVA coverage is crucial for patients with melasma, post-inflammatory hyperpigmentation, and photoaging changes, so this ingredient could be particularly helpful for skin of color patients and anyone treating pigmentary disorders,” she continued.
Dr. Yoo pointed to the filter’s broad-spectrum absorption profile. “It covers essentially the entire UVB and UVA range, with strong absorption peaks around 310 and 340 nanometers, which means it can meaningfully protect against both burning and deeper UVA1-driven photoaging.”
Photostability may also matter for formulators aiming for more robust performance under real-world use. “A major advantage of bemotrizinol is its photostability,” Dr. Yoo said. “Even after very high experimental UV doses, the molecule barely degrades, and it helps stabilize other filters like avobenzone.”
In practice, that means a sunscreen’s protection is more likely to stay close to the labeled SPF and UVA rating during real-world use, she added, “something that consumers and dermatologists would love to see given the recent media coverage worldwide about such discrepancies.”
Dr. Yoo further explained that available maximum-use pharmacokinetic data indicate minimal systemic exposure and low irritation potential. The data is reassuring, she shared: “in a 6% bemotrizinol formulation, systemic exposure in human volunteers was extremely low, often at or near the limit of quantification,” and “from an allergy and irritation standpoint, bemotrizinol has performed well in patch testing and post-marketing surveillance abroad.”
For formulators, she noted that the ingredient could widen available design options. “Right now in the U.S., we’re trying to engineer novel sun protection using a relatively old and dilapidated filter toolbox,” Dr. Yoo said. “Adding bemotrizinol to the monograph would let formulators hit higher UVA protection targets with fewer trade-offs in texture, so we can offer lighter, more elegant sunscreens without sacrificing science.”
“If bemotrizinol is ultimately granted GRASE status, it would be the first new U.S. sunscreen active in decades,” she added. “That’s not just a regulatory footnote—it means we can finally be on track to compete with our international counterparts, where photo-protection guidelines already rely on these newer molecules.”
AADA welcomes the proposal
In a statement issued today, the American Academy of Dermatology Association said it supports FDA’s move toward expanding sunscreen options for US consumers. “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,” said Susan C. Taylor, MD, FAAD, president of the association.
The organization emphasized the ongoing burden of skin cancer in the United States and longstanding calls for broader access to modern sunscreen actives. Dr. Taylor noted that the United States “lags behind many other countries that have nearly twice as many approved sunscreen ingredients,” and reiterated the Academy’s recommendations for use of broad-spectrum, water-resistant sunscreens with SPF 30 or higher when outdoors.