The Food and Drug Administration said Thursday that it will move to make sunscreen manufacturers increase the SPF in formulas and display ingredients clearly on their labels, hoping to ensure sun safety.
“Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays, yet some of the essential requirements for these preventive tools haven’t been updated in decades,” FDA Commissioner Scott Gottlieb said in a statement on the new proposed regulation. “The proposal we’ve put forward would improve quality, safety, and efficacy of the sunscreens Americans use every day.”
The rule would be meant to promote the safety of active ingredients in sunscreen. The FDA said that, over the past 20 years, new scientific evidence has emerged to inform which ingredients should and should not go into sunscreen. Of the 14 active ingredients used in sunscreens, only two are approved by the FDA for safety. The FDA requires industry data to evaluate the safety of the 12 remaining ingredients.
The FDA is proposing that labels clearly indicate which ingredients are included and that they call attention to the danger of skin cancer and aging, which some existing sunscreens may not be able to prevent. The FDA also plans to increase maximum SPF from 50+ to 60+. The FDA will permit the sale of sunscreens with an SPF value up to 80, but no higher, provided the manufacturer submits a New Drug Application to be evaluated and considered by the administration.
“To help make sure this effort is successful, the FDA is looking to industry to gather the data needed to help ensure that products marketed to offer protection from the sun’s effects are safe and deliver on these promises,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
The FDA’s news release encourages beachgoers to pay closer attention to the sun protection measures they take, keeping in mind that sunscreens are not the only protective element from the sun’s harsh rays and should be worn with hats and protective clothing.
