On Thursday, the FDA announced that it is beginning a process to update regulatory requirements for sunscreen products. The proposed rules seek to bring over-the-counter sunscreen regulation into the 21st century.
“Some of the essential requirements for these preventive tools haven’t been updated in decades,” FDA Commissioner Scott Gottlieb said in a statement. “Today’s action is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens.”
The FDA has reexamined some common active ingredients in sunscreens, and will continue to do so, looking to determine whether they are safe and effective. Of the 16 total active ingredients the agency is evaluating, two have been approved and two have been determined to be unsafe. The agency is asking the industry and other interested parties for additional data on the remaining 12, which includes the active ingredient oxybenzone.
Rowan Jacobsen wrote in Outside’s recent online feature “Is Sunscreen the New Margarine?” that oxybenzone has been found to be a hormone disruptor “that can be detected in users’ blood and breast milk.” It has already been banned in Hawaii and the western Pacific nation of Palau because it “mutates the DNA of corals and is believed to be killing coral reefs.”
According to David Andrews, a senior scientist at the Environmental Working Group, the burden to prove whether active ingredients like oxybenzone are safe is on the industry, and, if it cannot do so, those will be disallowed from over-the-counter sale. “In the meantime, those ingredients can stay on the market, they're not coming off the market, but the clock is ticking on them,” he said, adding that oxybenzone is in the majority of products that might be found at your local pharmacy.
The two active ingredients that have already been marked as safe are zinc oxide and titanium dioxide. The two that are no longer considered safe and effective for use are PABA and trolamine salicylate, which, according to Andrews, have not been in products on the market for years.
In issuing the proposal, the FDA is looking to establish what it calls “final monograph regulations” for over-the-counter sunscreens, something that is required by the Sunscreen Innovation Act. Essentially, this would create clear cut rules for the sunscreen industry. The deadline for that monograph is November. As for those ingredients still outstanding, “They can't be a part of the final monograph if they are not recognized as generally safe and effective,” said Andrews.
The FDA says additional data on sunscreens that come in the form of powders is needed to determine their safety. The same goes for new products such as wipes, towelettes, body washes, and shampoos.
In addition to the proposals regarding product form and ingredients, the agency also addressed labeling. The maximum SPF on labels is set to increase from 50+ to 60+ and active ingredient information would have to be conveyed on the front of the package, much like other over-the-counter drugs. Also, as a sunscreen’s SPF increases, its UVA radiation protection would have to increase by a similar magnitude, “to ensure that these products provide consumers with the protections that they expect.”
Andrews said the current rules were written when people would apply sunscreen when they went to the beach. Now, people apply it everywhere, all the time. According to him, the new proposal will even the playing field between the established companies with their preferred active ingredients and the ones popular in other countries that are vying for U.S. approval. “All these companies need to step up to the plate to validate themselves,” he said.