The U.S. Food and Drug Administration (FDA) has approved a new sunscreen ingredient, marking the first time in nearly two decades that a new active ingredient has been added to over-the-counter sunscreen products in the United States.
On June 9, the FDA authorized the use of bemotrizinol, a broad-spectrum UV filter designed to protect against both ultraviolet A (UVA) and ultraviolet B (UVB) rays. The decision represents a rare expansion of approved sunscreen ingredients in the U.S. market, where regulatory standards for sun protection products are stricter than in many other countries.
The approval comes as public health officials continue to stress the importance of sun protection, even as usage patterns and misinformation remain concerns. According to a recent survey by the American Academy of Dermatology, 57% of Americans say they regularly use sunscreen. However, the survey also found that one-third of respondents reported experiencing a sunburn in the past year. For consumers, this approval means they will soon have access to more advanced sun protection options that may offer better coverage and improved wearability compared to existing U.S. formulations.
[SEE: Surprising Facts About Sunscreen]
What Is Bemotrizinol?
Bemotrizinol is a chemical sunscreen ingredient that provides protection against both UVA and UVB radiation. UVA rays are longer-wavelength ultraviolet rays associated with skin aging, including wrinkles and premature skin damage, while UVB rays are primarily responsible for sunburns. Both types of ultraviolet radiation are linked to an increased risk of skin cancer.
According to the FDA, bemotrizinol has low levels of absorption through the skin into the bloodstream, a key consideration in determining safety for topical use.
The agency has classified the ingredient as “Generally Recognized as Safe and Effective (GRASE)” for use in sunscreen products intended for both adults and children aged six months and older.
The FDA said companies will be permitted to begin incorporating bemotrizinol into sunscreen formulations starting August 9, 2026.
[READ: Sunscreen Recommendations and Tips From Dermatologists]
How Was Bemotrizinol Approved?
Bemotrizinol has been used for years in sunscreen products in Europe and other international markets, where regulatory frameworks differ from those in the U.S. In many countries, sunscreens are regulated as cosmetics, while in the U.S. they are classified as over-the-counter drugs. This distinction requires more extensive safety and efficacy testing before ingredients can be approved.
“The FDA approval process reflects regulatory requirements, not how well an ingredient works,” says Dr. Mona Gohara, a board-certified dermatologist and associate clinical professor of dermatology at the Yale School of Medicine. “Unlike many countries, the U.S. regulates sunscreen active ingredients through a particularly rigorous over-the-counter drug review process, which can take years. Bemotrizinol has been used for years in Europe, Asia and other parts of the world, with strong data supporting its safety and effectiveness.”
The FDA’s decision makes bemotrizinol the first new active ingredient added to an over-the-counter sunscreen monograph under the streamlined review process established by the CARES Act of 2020.
“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” said Dr. Mike Davis, acting director of the FDA Center for Drug Evaluation and Research, in a statement. “The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”
[SEE: Best Dermatologist-Recommended Sunscreens for the Body.]
Sunscreen Use and Public Health Concerns
The approval comes as public health officials continue to stress the importance of sun protection, even as usage patterns and misinformation remain concerns.
The American Academy of Dermatology survey findings highlight a gap between awareness of sun protection and consistent, effective use.
The AAD also reported that nearly half of Americans, and 64% of Gen Z respondents, have encountered sunscreen misinformation online. Health experts say that false or misleading claims online about sun exposure and sunscreen safety can contribute to risky behavior, including intentional tanning and inconsistent use of protective products.
“While it’s encouraging that over half of Americans are using sunscreen, young people and adults are navigating an overwhelming amount of conflicting information about sun protection,” said AAD President and board-certified dermatologist Dr. Murad Alam in a statement. “Misinformation reinforces harmful tanning myths, leading people to underestimate the risks of UV light exposure and ignore protective measures. It’s important to evaluate the source of medical information and make informed skincare decisions by seeking advice from a board-certified dermatologist.”
Dermatology experts continue to emphasize that sunscreen remains one of several tools needed to reduce skin cancer risk, alongside protective clothing, shade and limiting direct sun exposure.
“It is also important to remember that sunscreen is just one way to protect the skin from the sun,” says Dr. Marisa Garshick, a board-certified medical and cosmetic dermatologist for MDCS Dermatology: Medical Dermatology & Cosmetic Surgery in the New York Metro region, “and it is also important to avoid peak hours in the sun, wear a wide brimmed hat and UPF clothing.”
[READ: 10 Ways to Spot Skin Cancer Before It Kills]
How Do I Know Which Sunscreen Is Best For Me?
With different ingredients, formulations and physical forms of sunscreen, deciding which one is best for you and your skin can be daunting. To cut through any confusion, you can always have a discussion with your dermatologist to determine what’s best for you. But there are some general tips experts encourage people to consider.
“Look for broad-spectrum protection, SPF 30 or higher, and a formula that fits your skin type and lifestyle. Whether it’s a lotion, fluid, stick, gel or tinted formula, consistency matters more than chasing a specific ingredient.”
This sentiment is echoed by Garshick, who reiterates the importance of matching your lifestyle and skin type to make sure you’re getting the best protection specific to you.
“Someone with acne-prone skin may prefer a lightweight, oil-free formula, while someone with dry or sensitive skin may benefit from a more cream-based, moisturizing formulation,” Garshick says. “Those with sensitive skin may opt for a mineral sunscreen containing zinc oxide or titanium dioxide as these are less likely to cause a reaction. For those who spend a lot of time outdoors, it is important to also look for a sunscreen that offers water resistance.”
But when it comes down to it, the most important thing is that you use it. “The best sunscreen,” says Gohara, “is the one you’ll actually use every day.”
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FDA Approves New Sunscreen Ingredient: What to Know About Bemotrizinol originally appeared on usnews.com
