Reports on the presence of a potential carcinogen in sunscreen may have some people thinking twice about their outdoor protection regimen. It turns out the sunscreen safety debate is neither new nor easy to solve.
Max Nisen, a Bloomberg Opinion columnist who covers the healthcare industry, answers questions about the past and future of sun protection. The conversation has been edited and condensed.
What's behind these new concerns about sunscreen?
Two recent reports highlighted potential sunscreen risks. In May, testing lab Valisure LLC found elevated levels of a cancer-linked chemical called benzene in sunscreens made by Johnson & Johnson, among others. It may result from contamination in manufacturing, and J&J recalled the products in question in July. And last week, researchers petitioned the Food and Drug Administration to recall all sunscreens that contain the commonly used chemical octocrylene after finding it was associated with the presence of a possible carcinogen and hormone disruptor called benzophenone.
Also read: Your sunscreen might contain a carcinogen
Do we know for sure that the ingredients highlighted in these reports cause health problems?
Benzene is a known carcinogen. What's unclear is whether the concentrations found in the products highlighted in the May report are high enough to be a danger, or are absorbed through the skin or inhaled (in the case of sprays) in a quantity sufficient to cause issues during regular use of sunscreen. Even the CEO of the testing lab that found the possible contamination has noted that it doesn't appear to be an issue of specifically heightened concern with sunscreen. Benzophenone is listed as a possible carcinogen by the World Health Organization, though that designation is based on animal studies. It may also disrupt the function of the reproductive system. Once again, though, it's not certain if enough is absorbed that it is an issue.
Are these risks new? What are regulators doing about it?
While the specific risks highlighted this year are new, chemical sunscreens in general have been under heightened scrutiny for some time. In 2014, an FDA advisory panel concluded that there wasn't enough evidence to declare many sunscreen ingredients safe and effective. In 2019 and 2020, the agency published data showing that various chemicals commonly used in sunscreens are absorbed through the skin into the bloodstream at potentially significant levels. Blood tests alone don’t mean they're unsafe, but it does mean we need a lot more data about potential effects over many years. In 2019, the agency finally released a proposed new rule that designated only two active sunscreen ingredients — mineral-based zinc oxide and titanium dioxide — as clearly safe and effective. It said two other ingredients, para-aminobenzoic acid (PABA) and trolamine salicylate, shouldn’t be used and requested more information on 12 other approved ingredients while reserving the option to remove products if companies didn't commit to safety studies. A Covid relief package passed last year gave the FDA more power to regulate products like sunscreen but paused its previously planned new rules. A new set of regulations due by late September is likely to include many of the 2019 recommendations.
Why is the FDA having such a hard time regulating these products, and why do outside researchers appear to be doing the agency’s job?
Sunscreens were largely approved as over-the-counter drugs decades ago, when safety and efficacy standards were weaker. Changing regulations on over-the-counter products has been a sluggish multi-year process. Additionally, the agency generally asks companies to submit safety data as part of an approval process; getting sunscreen makers to do studies after the fact has proved difficult. After all, it's not exactly in a manufacturer's interest to conduct studies that may hurt sales. Running the sort of studies needed to truly determine safety and the risk-benefit profile of various products would be very expensive, and without extra funding, there's only so much the FDA can do on its own. The agency's updated regulatory process may make it easier to play hardball with manufacturers.
Does Europe do a better job of regulating sunscreen?
In most of the world, including Europe, sunscreens are regulated as cosmetics. The resulting flexible regulatory process means that a number of potentially more effective and safe ingredients, including Tinosorb and Mexoryl, are more widely available. Europe also has higher standards for sun protection and allows more combinations of ingredients, so sunscreens formulated there can be more effective than those on sale in the U.S. Manufacturers have been trying to get new ingredients approved in the U.S. for years, with little success. The FDA seems to be applying heavy scrutiny to new ingredients it's been unable to apply to older ones, possibly leaving Americans without better options.
Should I be more worried about these chemicals than the risk of sun damage or skin cancer?
At this point, the dangers of chemical sunscreens are still uncertain, especially relative to the risk of developing skin cancer. That's likely one reason the FDA has been slow to act. The agency has to balance potential safety risks against the possibility of removing effective products or scaring people from protecting themselves against sunburn and skin cancer. Definitely keep an eye out for recalls and updated FDA guidance and consider mineral options if you're the cautious type, but don't avoid sunscreen this summer.
Should we all just use mineral sunscreen, like pregnant women are advised to, to be safe? Is it just as good as the chemical-based products?
Mineral sunscreens have good and bad qualities. They are less likely to be absorbed into the bloodstream. Unlike chemical sunscreens, which are absorbed into the skin over time, mineral sunscreens create an external barrier to the sun and start working immediately. Zinc oxide in particular also protects against both of the two types of dangerous ultraviolet rays (UVA and UVB), unlike some chemical ingredients. However, some people don't like the potentially pasty cosmetic consequences of mineral products, and some consumer testing finds mineral sunscreens may not always be as protective. But especially if you're using a whole lot of sunscreen, they may be the safest bet.