It has been decades since the FDA approved a new sunscreen ingredient, but clinicians and manufacturers hope a just-signed law may break the logjam.

Separately, at the same time, an ingredient — bemotrizinol (Parsol Shield) — that has been wending its way through the FDA under previous evaluation criteria is poised to be approved. New formulations using that ingredient could be on the market as soon as July 2026.

The SAFE Sunscreen Standards Act was signed into law on November 13 as part of the reauthorization of the Over-the-Counter Monograph User Fee Act, which itself was incorporated into the budget package that re-opened the federal government.

A key aspect of the SAFE Act — which had broad bipartisan support — is that it would require the FDA to accept data generated by alternatives to animal testing.

Congress has tried at least twice in the last decade to prod FDA to figure out a better and faster way to approve sunscreens: in 2014 with the Sunscreen Innovation Act, and again in 2020, through the CARES Act, which sought to modernize the over-the-counter drug process.

Still, there has not been a new ingredient approved since 1999.

SAFE gives new hope, said dermatologists.

Susan C. Taylor, MD, president of the American Academy of Dermatology (AAD), said in a statement provided to Medscape Medical News that the organization is a member of the SUNucate Coalition that endorsed SAFE. The AAD “hopes this new law encourages the Food and Drug Administration to approve innovative and new sunscreen ingredients that will help save the lives of Americans from skin cancer,” Taylor said, noting that almost 20 Americans die from melanoma every day. Taylor is professor of dermatology at the University of Pennsylvania, Philadelphia.

“While there are many safe and effective sunscreens in the US, Americans deserve continued innovation in sun protection,” Deborah S. Sarnoff, MD, president of The Skin Cancer Foundation, said in a statement from the Foundation. “The SAFE Sunscreen Standards Act is a step in the right direction in our battle against the world’s most common cancer,” she said.

“We haven’t had a new sunscreen in over 20 years,” said Jane Yoo, MD, a dermatologist in private practice in New York City. Limited choices discourage many people from using sunscreen, she told Medscape Medical News.

Consumers “like the feel of and quality of certain formulations, and those formulations are not available in the United States,” said Yoo, assistant clinical professor at the Icahn School of Medicine at Mount Sinai, New York City. She also noted that newer filters in other countries provide additional protection against ultraviolet A light and offer formulations that are more attractive or tolerable to specific groups, such as people of color and individuals who have had skin cancer.

A statement from the Personal Care Products Council, which represents sunscreen manufacturers, said that the law “is a significant step in promoting skin cancer prevention by ensuring US residents have access to innovative and effective sunscreen ingredients. It is also meaningful progress towards the regulatory acceptance of nonanimal test methods.”

Joel Roberson, a Washington, DC-based food and drug law attorney who is a policy adviser to the Public Access to SunScreens Coalition told Medscape Medical News that he thinks the new law means that “you will see companies that take a renewed interest in the United States, that may have been in a wait-and-see mode, or may have made a decision previously to abandon the US market.”

The FDA may also be ready to move on to a new regulatory framework, he said. Roberson referred to a blog post from the FDA, which said that the agency had “taken a number of steps to reduce and minimize animal testing for sunscreens,” and that it was encouraging companies to find ways to reduce the use of such testing.

Removal of Key Barriers

Requiring the FDA to accept alternatives to animal data removed a key barrier that had been holding up approvals of sunscreen ingredients, including eight that have been at the agency for decades, said Roberson.

Companies sell their sunscreens globally and the EU and other nations have long banned animal testing of sunscreens. Manufacturers either had to engage in animal testing to seek US approval or stay out of the US market.

Others hailed the acceptance of alternatives to animal testing. “The adoption of nonanimal data for sunscreen evaluation is long overdue,” the Physicians Committee for Responsible Medicine, said in a statement. “These outdated testing standards have significantly delayed innovation,” the statement said, adding that because many sunscreens available in other countries have been in use for years, “there is a wealth of human data, or real-world evidence, that can be leveraged to support the safe use of these sunscreen ingredients.”

Another major obstacle to FDA approval has been the agency’s requirement that companies perform a “maximum usage trial,” Roberson said. That is not required by other global regulatory agencies. SAFE, however, “requires the FDA to consider tests that include alternative study methods, like real-world evidence,” to determine safety and effectiveness, which does not lower the bar for safety, he said.

New Products in 2026

Roberson said he believes that the FDA would start accepting new alternative data from manufacturers immediately, although he was not aware of any companies ready to seek approval just yet.

But at least one company, DSM-Firmenich, said that it expects its sunscreen ingredient — bemotrizinol (Parsol Shield) — will be approved in June. Bemotrizinol has been used in Europe since 2000 and is approved in dozens of countries, Carl D’Ruiz, MPH, DSM-Firmenich’s North America head of Science Advocacy and Business Development, told Medscape Medical News.

The company filed for FDA approval in 2018, but that came after a years’-long odyssey at the agency through shifting regulatory requirements, according to D’Ruiz. At a meeting in October, the agency told the company it should expect a final decision in late December. The FDA then will collect comments and respond, giving it until June to post the approval.

The company aims to have its ingredient ready for US manufacturers soon thereafter, D’Ruiz said. But he noted that products made in other countries could potentially be available in the US quickly. “We could start seeing these products on the marketplace, beginning as early as July,” he said.

Yoo said she expects patients to quickly gravitate toward new products. “People like what they can’t have,” she said, noting that many have been exposed to different options while traveling, shopping online, or through posts on social media.

“Having so many different options is really the key,” said Yoo.

Yoo reported being a consultant for L’Oreal but not on sunscreens.

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.