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The sunscreen market in the United States has remained largely stagnant for the past 25 years, as many skincare and cosmetic companies have failed to get new active ingredients approved. Legislation recently introduced in the House of Representatives and the Senate seeks to change that.

Both versions of the bill, called the SAFE Sunscreen Standards Act, were introduced by a bipartisan group of lawmakers who say that consumers need more effective sunscreens to help prevent skin cancer.

In contrast to some European and Asian countries, sunscreens in the U.S. are regulated by the U.S. Food and Drug Administration as over-the-counter drugs instead of cosmetics, meaning they must fulfill a long list of requirements to obtain approval. This bottleneck has led to a lagging American market that offers limited options.

“The U.S. has a lot less choice,” said Steve Xu, a dermatologist and medical director of the Querrey Simpson Institute for Bioelectronics at Northwestern University. “It has a lot less products because of the increased requirements that are necessary before a sunscreen can be sold.”

To modernize the market, the new bill aims to change some requirements, such as encouraging alternatives to animal testing, and ease an approval process that many experts call overly restrictive. Such a revamp could potentially allow better sunscreen options to enter the market, which proponents say may boost use among populations with lower uptake, including people with darker skin. It’s not clear whether leadership at the Department of Health and Human Services will be supportive; Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” initiative has been associated with unfounded skepticism and misinformation around some sunscreen ingredients.

The legislation, if passed, could represent a modest, but meaningful change in how individuals can protect themselves from skin damage and cancer, said Xu. “More choice, more clarity on regulation — these are things that are good, incremental steps forward.”

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More than 210,000 new skin cancer cases are expected to be diagnosed in the U.S. this year, a number that has been on the rise. Sun-safe practices, including the use of sunscreens, have been an important tool in counteracting that increase.

Sunscreens work to block sun damage through ultraviolet, or UV, filters, and generally fall into two categories: Mineral sunscreens are made out of particles of inorganic materials — zinc oxide or titanium dioxide — while chemical sunscreens are made from organic molecules. Both types of filters protect the skin by absorbing UV rays and converting the energy to heat, while mineral sunscreens also scatter some UV light. Active ingredients used in both types have been regulated as drugs, which the FDA categorizes as products “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” or “affect the structure or any function of the body of man or other animals.”

“More choice, more clarity on regulation — these are things that are good, incremental steps forward.”

The FDA drug approval process can be costly and lengthy, though. For example, DSM-Firmenich, a nutrition and health company based in Switzerland and the Netherlands that makes sunscreens, has spent 20 years and $18 million trying unsuccessfully to get FDA approval for bemotrizinol, an ingredient that has long been available in European sunscreens and found to be safe and effective. And even though U.S. sunscreens have a more rigorous approval process, one small 2017 study found that they may actually be less effective at blocking certain UV rays by European Union standards.

The lack of progress has exasperated many doctors, who have been waiting for improved sunscreens to recommend to their patients. “I’m quite familiar and somewhat frustrated by the slow pace of the movement,” said Henry Lim, a dermatologist at Henry Ford Health, a health care system based in Detroit.

While the FDA should ensure that sunscreens are safe, some of their requirements are too strict, said Adam Friedman, a dermatologist at the George Washington University School of Medicine and Health Sciences. Many countries in Europe, for example, don’t require investments into animal testing, but their products have not been found to compromise consumer safety.

“There are so many papers out there, huge numbers of people and subjects over the years, showing that sunscreen is safe and effective,” said Friedman, who wrote a letter in support of the House bill to the Committee on Energy and Commerce, which is currently reviewing the legislation. “But, according to FDA, that’s not sufficient.”

The Environmental Working Group, an activist organization that advocates for safe sunscreens, acknowledges that the FDA’s process has “slowed the approval of new ingredients that may be protective and safer.” They insist, though, that the problem would be solved, in part, by providing more funds for FDA. And, in a July statement, the EWG said that the bill “would lower the bar for sunscreen safety by allowing ‘real world evidence’ and marketing history that will not address concerns posed by the chronic risks posed by sunscreen chemicals.” (Friedman noted, however, that the chronic risks that people and organizations like EWG typically cite — such as the potential for the ingredient oxybenzone to disrupt hormones — are based on preliminary studies that don’t reflect real-world circumstances.)

“There are so many papers out there, huge numbers of people and subjects over the years, showing that sunscreen is safe and effective.”

One of the biggest changes the bill proposes is the type of data the FDA will accept for its review process. The agency currently requires that companies test products on animals, but for many companies, particularly those in Europe, such testing is not practical, is discouraged, or is even outright banned. The bill would allow the FDA to consider other data, including real-world evidence and observational studies.

Animal testing was “a gold standard 25 years ago, but science has changed since then,” said Lim. “There are many other in vitro methods that would be just as reliable, as reproducible.” Meanwhile, there are years of real-world data on safety and effectiveness from other countries. The hope is that such data could be used in the FDA review process.

In response to questions from Undark, including if the FDA would be open to the changes, an email from the agency stated that the “FDA is unable to comment on pending or proposed legislation.”

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Beyond expanding product variety for all consumers, Xu pointed out, newer formulations could help one group that has disproportionately low sunscreen uptake: people of color. A 2024 survey found that 25 percent of individuals with darker skin used sunscreen daily compared to 31 percent of White individuals even though they expressed a willingness to use it.

One reason for the low uptake is that some active ingredients used in mineral sunscreens, such as zinc oxide or titanium dioxide, leave a white cast on darker skin, which 25 percent of people of color reported as a deterrent to using sunscreen (compared to only 7 percent of White individuals). In his research, Xu found that people with darker skin would like more options for sheer and tinted sunscreens, which tend to be more costly, another 2024 study found.

Unappealing formulations deter the population-at-large as well. A 2020 survey conducted in Germany found that 36 percent of surveyed participants don’t use sunscreen because they find it too greasy or sticky. “If it’s thick and goopy and it’s bright white, you’re not going to have adherence,” said Friedman. “So, we need options that will fit everyone’s needs.”

The Senate’s Health, Education, Labor, and Pensions Committee already voted to advance a legislation package that includes the SAFE Sunscreen Standards Act. In the House, the bill has been referred to the Committee on Energy and Commerce, which will review the legislation and make suggested amendments if necessary. “I think we’re going to know something one way or another end of September,” Freidman said.

While many experts are optimistic about the legislation passing, they are still cautious about its potential impact. “I don’t think it’s going to be how we’re going to win the war on skin cancer,” said Xu. That would require more dermatologists, early cancer detection, increased public awareness, and a host of sun protecting strategies, including protective clothing.

But if the legislation passes, it could provide consumers with other tools to protect themselves from harmful UV radiation that the U.S. has lacked for the last 25 years, he added: “It’s a step in the right direction.”

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