Sunscreens remain on shelves despite concerns
• US authorities have still not ordered removal of risky ingredients that give chemical lotions and sprays their protective power
In 2019 the US Food and Drug Administration (FDA) 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 cannot get to an sun protection factor 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, a research and advocacy organisation in Washington, DC.
That drop has been fuelled more by consumer sentiment than official action: the FDA hasn’t ordered the removal of oxybenzone from sunscreens — or assured the public that it is 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, 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 Environmental Working Group.
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 attentiondeficit/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 EU, 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 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 by Bloomberg News.
The FDA doesn’t want to discourage people from using sunscreen. “Given the recognised 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 40plus years ago, it didn’t require companies to supply much data on the chemicals. In 2020 the FDA published a study in the Journal of the American Medical Association 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 has 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 now available for UVA protection in the US. The sunscreen industry has not yet produced the safety and effectiveness data the FDA requires for newer ingredients.
Dutch company DSMFirmenich 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 is 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 totalled $960m in 2021 and is expected to reach $1.6bn 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, coleader of the University of Utah Huntsman Cancer Institute’s Melanoma Centre, 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, a sun protection factor above 30 doesn’t provide significantly greater protection, say Grossman and Dobos. Sun protection factor 30 blocks 97% of UVB rays, while 50 blocks 98%, and it takes higher concentrations of ingredients to reach higher sun protection factors. The FDA has proposed prohibiting sunscreen makers from selling products labelled with a sun protection factor 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 emphasise other things they can do besides sunscreen that can make a difference.”
THE FDA HASN’T ORDERED THE REMOVAL OF OXYBENZONE FROM SUNSCREENS — OR ASSURED THE PUBLIC THAT IT IS SAFE
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