By Anna Edney

In 2019 the Food and Drug Administration told sunscreen manufacturers it had safety concerns about 12 ingredients that give so-called chemical lotions and sprays their protective power. The one that became the poster child for concern among researchers and consumer advocates was oxybenzone. It can upset the balance of hormones in ways that may increase cancer risk and lead to shorter pregnancies as well as lower testosterone levels in adolescent boys, studies have shown. Oxybenzone has been found in amniotic fluid and breast milk.

Four years later, oxybenzone has been largely eliminated as an ingredient—though manufacturers typically can’t get to an SPF above 50 without adding it to the mix, so it can still be found in popular brands. The percentage of chemical sunscreens with oxybenzone on the market fell from 60% in 2019 to 13% this year, according to the Environmental Working Group (EWG), a research and advocacy organization in Washington, DC.

That drop has been fueled more by consumer sentiment than official action: The FDA hasn’t ordered the removal of oxybenzone from sunscreens—or assured the public that it’s safe. After oxybenzone and another chemical were linked to coral reef damage in Hawaii, the state banned the sale of sunscreens with the ingredients starting in 2021. Two counties, including Maui, have since prohibited the sale of any chemical sunscreens.

And not much has changed with the other ingredients the FDA raised concerns about. At the time, the agency said that without more data it couldn’t continue to let them be used in sunscreens. But the industry, led by a lobbying group called the Personal Care Products Council (PCPC), asked the FDA to wait; the council said it would get the FDA more information by this year. That hasn’t happened. “We still have not seen any data submissions or plans for data submissions,” says Homer Swei, senior vice president for healthy living science at the EWG.

A PCPC spokesperson says the FDA’s work during the Covid-19 pandemic diverted the agency from providing guidance the industry needed to gather the data, delaying what the council referred to as a draft timeline. The PCPC sent a letter it sent the FDA in September 2021 updating the agency on its progress. An FDA spokesperson says, “The topic of sunscreen ingredients remains a high priority for the agency, and we will continue to work as expeditiously as possible with our external partners to best protect public health.”

Oxybenzone and other ingredients in question, such as homosalate and avobenzone, are known as endocrine disrupters. The National Institute of Environmental Health Sciences has linked endocrine disrupters to attention-deficit/hyperactivity disorder in addition to the cancer and fertility issues. In the US, sunscreen makers use homosalate in concentrations as high as 15%; in the European Union, the limit is 0.5%.

The concerns aren’t limited to endocrine disrupters. Research published in 2021 found that some sunscreens with the popular ingredient octocrylene tested positive for benzophenone, a possible carcinogen that can form when octocrylene breaks down over time. German chemical manufacturer BASF SE told sunscreen makers that year it would stop supplying octocrylene after “listening to the growing concerns” about it. The company stopped fulfilling orders in December 2022, according to a letter obtained.

The FDA doesn’t want to discourage people from using sunscreen. “Given the recognized public-health benefits,” the spokesperson says, “the FDA is committed to finding ways to facilitate the marketing of sunscreen products.” But the agency also hasn’t approved newer, alternative ingredients. It considers sunscreens over-the-counter drugs, though when it began regulating their ingredients 40-plus years ago, it didn’t require companies to supply much data on the chemicals. In 2020 the FDA published a study that found sunscreen ingredients entered the bloodstream after just one use and can stay in our systems for as long as 21 days. The study found that oxybenzone and homosalate lasted the longest.

European regulators have moved much faster to get newer chemicals to market, in large part because they treat sunscreens more as cosmetics, and don’t require as much data as the FDA does now. Some ingredients in use in the EU aren’t absorbed in the same way as older ingredients on the market in the US, researchers say. “We really need to develop these better ingredients that have a better safety profile,” says Kelly Dobos, a cosmetic chemist who’s worked in the industry and is now a consultant.

Safety concerns aside, the 12 ingredients the FDA has flagged mainly protect against ultraviolet B rays, which cause sunburn. In Europe, newer formulations also are better at boosting protection from UVA rays, which penetrate the skin and can cause cancer. Avobenzone and the mineral zinc are considered the best ingredients currently available for UVA protection in the US. The sunscreen industry hasn’t yet produced the safety and effectiveness data the FDA requires for newer ingredients.

Dutch company DSM-Firmenich AG has tried to get FDA approval for bemotrizinol, an ingredient used in the EU for more than 20 years. DSM has yet to successfully navigate the FDA’s process, though Carl D’Ruiz, a senior manager for scientific advocacy and business development at DSM, says it’s aiming for FDA clearance by the first half of next year. “Unfortunately some other companies that have been working to get these new [active ingredients] approved in the US have dropped work on it because it takes so long,” Dobos says. The FDA says it “continues to encourage interested parties to work with the agency to provide necessary data.”

In the meantime, consumers are turning to mineral sunscreens. Popular versions such as zinc oxide and titanium dioxide, which the FDA has said are safe, sit on the skin and block the sun’s rays. Zinc oxide is a “broad spectrum” sunscreen, meaning it blocks UVA and UVB rays. The global mineral sunscreen market totaled $960 million in 2021 and is expected to reach $1.6 billion in 2031, according to Transparency Market Research in Wilmington, Delaware. They have a reputation for being harder to rub in than chemical varieties, making people look like ghosts, though many brands have solved this issue and some versions are even tinted.

Douglas Grossman, co-leader of the University of Utah Huntsman Cancer Institute’s Melanoma Center, advises patients to use a mineral sunscreen. “It avoids all the issues with chemical sunscreens,” he says. “It just makes common sense that you put something on the skin and it blocks the UV, it’s going to work better than if you have something that absorbs into the skin and the UV penetrates the skin.”

With both chemical and mineral sunscreens, an SPF above 30 doesn’t provide significantly greater protection, say Grossman and Dobos. SPF 30 blocks 97% of UVB rays, while SPF 50 blocks 98%, and it takes higher concentrations of ingredients to reach higher SPFs. The FDA has proposed prohibiting sunscreen makers from selling products labeled with an SPF higher than 60.

Of course, avoiding the sun in the middle of the day and wearing protective clothing such as a hat and long sleeves are also effective tools in combating the negative effects of sun exposure. “When I talk to patients,” Grossman says, “I really try to emphasize other things they can do besides sunscreen that can make a difference.”