Stock image of a woman in a beach hat and sunglasses applying sunscreen on a sunny day.

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Jasmine Laws

By Jasmine Laws

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The biggest shift in sunscreen regulation in more than 25 years has taken place in the United States, as the Food and Drug Administration (FDA) approved a highly effective ultraviolet (UV) filter already widely used abroad.

At the end of last year, the FDA announced a proposal to expand its list of active ingredients approved for sunscreen products by adding bemotrizinol, a highly photostable agent that retains its effectiveness even after prolonged sun exposure. On Tuesday, the FDA announced it had added the compound to its list of permitted sunscreen active ingredients.

The move has been applauded by dermatologists, given that skin cancer remains the most common cancer in the U.S. today. It is currently estimated that one in five Americans will develop skin cancer in their lifetime.

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"This is overwhelmingly a positive development," Dr. Mona Gohara, a professor of dermatology at Yale University, told Newsweek.

"Adding another well-studied sunscreen ingredient gives Americans access to more options and may help create sunscreens that are more elegant, comfortable, and easier to wear every day," she added. "Since sunscreen only works when people actually use it, that matters."

Dr. David Fisher, a professor of dermatology and pediatrics at Harvard University, told Newsweek this was a "positive" move.

"The U.S. chemical sunscreen market needs better UVA-blocking compounds, which bemotrizinol does offer," he said.

What Is Bemotrizinol?

Bemotrizinol is a "highly effective broad-spectrum UV filter that protects against both UVA rays, which contribute to aging, pigmentation, and skin cancer, and UVB rays, which cause sunburn and also play a major role in the development of skin cancer," Gohara said.

She explained that it is also "one of the most photostable sunscreen ingredients available, meaning it doesn't break down easily in sunlight and can help stabilize other sunscreen ingredients."

Bemotrizinol has also been used safely for years in Europe, Asia, Australia, and other parts of the world, she added.

Stock image of a woman in a beach hat and sunglasses applying sunscreen on a sunny day.

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How This Would Affect Consumers

The new ingredient could drive several noticeable changes for consumers:

Why Is the FDA Approving Bemotrizinol Only Now?

The answer to that question is largely to do with the way the FDA regulates sunscreen.

"The FDA's sunscreen approval process is unique because sunscreen ingredients are regulated as over-the-counter drugs rather than cosmetics," Gohara said. This means that manufacturers must provide "extensive safety and efficacy data that meet FDA standards."

This is on the basis that sunscreen "helps prevent sunburn and reduce the risk of skin cancer and early skin aging caused by the sun," and under U.S. law, products intended to "diagnose, treat, mitigate, or prevent disease are regulated as drugs," Sally Pipes, president and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute, told Newsweek.

If sunscreen were regulated more like a cosmetic product, manufacturers "would not generally need FDA premarket approval for every new ingredient before selling it," Pipes explained. They would still be "legally responsible for product safety, accurate labeling, good manufacturing practices, and compliance with FDA rules."

"The FDA could still act against unsafe, adulterated, or misbranded products," she said, but the difference is that "products could reach consumers far more quickly."

Fisher said the FDA's more rigid review of sunscreen could also be out of caution after a number of studies published a few years ago found that sunscreen chemicals (not bemotrizinol) "were unknowingly penetrating through the skin and entering the bloodstream even after normal skin applications."

"While it was not clear that elevated blood levels of sunscreen chemicals were necessarily dangerous, it also has not been certain that there is no toxicity risk— leaving the dermatology community in an uncertain state of how to balance UV-skin protection versus unknown risks from systemic (blood level) exposure of the topical ingredients," he said.

The company seeking approval for bemotrizinol spent 20 years and millions of dollars trying to secure FDA authorization, according to a report by beautymatter.com.

So while bemotrizinol has a history of international use and a strong safety record, the FDA requires its "own rigorous review process before approving a new active ingredient for the U.S. market," Gohara said.

This means that, compared with other countries, the U.S. has approved relatively few UV filters simply because the "regulatory pathway is lengthy and demanding," Gohara said. "The goal is consumer safety, but the tradeoff is that innovation often reaches American consumers much more slowly than it does elsewhere in the world."

Some experts think there may even be a risk to this rigorous regulation.

"That level of scrutiny may make sense for experimental drugs with potentially dangerous side effects. It makes far less sense for topical sunscreen ingredients that have been used safely overseas for decades," Pipes said in an op-ed shared with Newsweek.

So while the FDA's announcement is a welcome development, "what is needed is a broader modernization of how sunscreen is regulated in the U.S.," Pipes said. "In the fight against skin cancer, regulatory delay is not a neutral act. When public officials keep better sunscreens off the market for decades, Americans are left relying on yesterday's protection against today's risks."

George Mason University economist Alex Tabarrok also described this problem in an op-ed as the "invisible graveyard" of FDA regulation, where lives aren't put at risk by problematic products reaching the market, but rather by beneficial ones not reaching it.

Could This Reduce Skin Cancer Rates in the US?

Skin cancer remains the most common cancer in the U.S., with tens of thousands of melanoma cases diagnosed each year and millions treated for other forms of the disease. Melanoma, a type of skin cancer, kills around 20 Americans every day.

Sunscreen is one of the most effective preventive tools available, capable of reducing the risk of melanoma and other skin cancers when used properly, according to guidance from the Centers for Disease Control and Prevention (CDC).

However, the U.S. currently has a "limited sunscreen toolbox," Gohara said, which can make it harder for companies to create products that are "lightweight, cosmetically elegant, and appealing across a wide range of skin types and skin tones." Fewer choices can lead to potentially lower sunscreen use, so a more advanced filter like bemotrizinol could improve both protection and usability.

Gohara stressed that bemotrizinol "won't replace the fundamentals," such as "wearing a broad-spectrum SPF 30 or higher, seeking shade, and using protective clothing." But it may make "sun protection easier and more appealing for millions of Americans."

What Sunscreen Should You Be Using?

The American Academy of Dermatology recommends the following:

Common dermatologist-backed options include both mineral and chemical sunscreens, depending on skin type:

Update 6/1/26, 3:26 a.m. ET: This article has been updated with comment from Dr. David Fisher.

Update 6/10/26, 4:21 a.m. ET: This article has been updated with a new headline and additional information.

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