Coming To America

FDA’s approval of bemotrizinol (BEMT) arrived with fanfare on June 9, 2026. Already approved in Europe, South Korea and Australia, BEMT is now on the list of permitted sunscreen active ingredients in the US,  opening up new formulation possibilities for sunscreen brands.

The fact that this is the first active ingredient added to the OTC sunscreen monograph since the late 1990s isn’t lost by anyone in the industry.

“The approval of Bemotrizinol represents one of the most significant advancements in U.S. sunscreen science in more than 25 years,” said Akshay Talati, chief innovation officer, Supergoop!. “Expanding the palette of approved UV filters in the US creates new opportunities for formulators to optimize protection, aesthetics, photostability, and wearability in ways that can further elevate the sunscreen experience for consumers.”

The process for BEMT’s greenlight in the US was far from smooth.

“The road to this announcement was rocky and the process to arrive at that decision was tedious,” said Dr. Nadim A. Shaath, president of Alpha Research & Development Ltd., and Happi’s longtime columnist covering sunscreens. “It took over 20 years of lobbying, meetings, and several Acts of Congress. First the SIA (Sunscreen Innovation Act) in 2014 and the CARES Act in 2022 as well as the recent directives from Congress. Credit to move the needle must be given to DSM. They did the follow up and the extensive testing required by the FDA.”

Benefits of BEMT

BEMT is a meaningful addition to the US chemist’s kit.

“BEMT is a unique UV filter with both a substantial UVB and a UVA absorption that provides broad spectrum protection and has been in use safely and effectively in the rest of the world, outside the USA, for 20 years,” Shaath noted. “It is photostable, unlike Avobenzone, covers the full UV spectrum including the so-called 320 nm gap and above all, it is compatible with both ZnO and TiO2 allowing for ‘hybrid’ formulations with other UV absorbers.”

Better Sunscreens = Better Compliance

Industry has been focused on formulation aesthetics for years. For many, BEMT’s approval in the US ramps up the possibilities.

“What makes this especially important is what it enables next,” said Asha Patel Shah, MD, MBA, FAAD, head of medical affairs, North America, Skin Health & Baby at Kenvue. “Next-generation filters like bemotrizinol (BEMT) can support stronger, more photostable UVA/UVB protection, while also improving the sensory experience—delivering lighter-feeling formulas with less white cast and better wearability. That combination—better protection and better aesthetics—is critical to Americans for consistent and daily sunscreen use.”

According to Patel Shah, Kenvue is actively preparing new products that incorporate BEMT, and is aiming to offer these products consumers later this year.

“More broadly, we see this as the start of a new wave of innovation rather than a single launch moment, so you can expect continued progress over time as formulations evolve,” she said.

Dermatologists are looking forward to the wider array of finished products that will increase daily compliance.

“Having another FDA-recognized sunscreen filter available to consumers expands our options and supports the development of more elegant, effective formulations that can encourage daily sunscreen use,” said Dr. Jessica Weiser, board-certified dermatologist and founder of Weiser Skin MD. “Until now, with the exception of zinc oxide and titanium dioxide—which can leave a white cast—no US-approved ingredient covered the full UVA/UVB spectrum. “This added photoprotection in an elegant sheer formulation and with top-rated safety should encourage even more Americans to wear sunscreen on a daily basis with ease.”

Better sunscreens are vital to public health, and BEMT’s approval is welcomed by dermatologists that witness the impact of sun exposure on skin health.

“The FDA’s Final Order approving bemotrizinol is a landmark moment for sun care in the United States,” said dermatologist Dr. Jane Yoo. “It is a pivotal time that I have been working towards for years as a dermatologist, Mohs surgeon, and health policy advocate. In my practice, I see the real consequences of inadequate photoprotection every single day when treating skin cancers such as basal and squamous cell carcinomas and melanomas.”

“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” noted Dr. Karen Murry, MD, director of the Office of Nonprescription Drugs in CDER. “Now, through the best available science and updated regulatory framework, we can work with companies to get innovative products to market in a more efficient manner than ever before.”

Kenvue is already moving. Patel Shah said the company is “actively preparing” new products incorporating BEMT for consumer availability later this year.

Accordin to Patel Shah, the approval “directly supports one of the most important and underutilized tools in public health: consistent and daily sun protection.”

The consensus is: BEMT’s approval is welcome, but overdue.

“BEMT is a great start, but we wish the approval process for new SPF filters were more regular and did not take decades,” Black Girl Sunscreen Founder Shontay Lundy told Happi.  Having anticipated approval for almost 2 years, the brand began development to be ready for this new active to be available in the market, she asserted.

What’s Ahead?

Stakeholders are hopeful that FDA’s action could be an inflection point.

Said Talati, “…this milestone helps pave the way for future OMOR applications of new UV filters and continued advancement of sunscreen science in the United States.”

“With the recent BEMT approval, we hope this may help streamline the SPF monograph, so we have more tools to work with to make SPF products feel great and be efficacious,” noted Dinh Pham, director of brand development and sales, Black Girl Sunscreen.

Dr. Yoo shared her optimism, too.

“BEMT’s photostability, broad-spectrum UVA coverage, and cosmetically elegant profile give American formulators what they’ve been missing,” she said. “This approval gives patients sunscreens they will actually use daily and consistently. For patients who need increased photoprotection including those with melasma, a history of skin cancer, or sensitive skin, this shift cannot come soon enough.”

FDA’s final order takes effect August 9, 2026.