FDA Calls for New Restrictions on Ingredients in Many Sunscreen Products

The US Food and Drug Administration proposed new regulations on over-the-counter sunscreen in an effort to keep up with the latest scientific and safety information. The recommendation is available in a recent news release, which addresses the safety of common sunscreen ingredients, as well as dosage forms, sun protection factor (SPF) and requirements. The organization also wants labels to be easier to read.

“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," says FDA commissioner Scott Gottlieb. "Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin. The proposal we’ve put forward would improve quality, safety and efficacy of the sunscreens Americans use every day.”

Zinc oxide and titanium dioxide are the only two of the 16 main ingredients currently used in over-the-counter sunscreen products considered safe. The FDA named two ingredients, PABA and trolamine salicylate, as not permitted for use in non-prescription sunscreen products, and is asking the industry for additional data on the 12 other ingredients.

Additionally, it proposes raising the maximum SPF labeling on products from 50+ to 60+. The regulation would also require all products labeled with an SPF of 15 or greater to offer broad-spectrum protection against UVA rays, which are usually associated with early aging of the skin, and UVB rays, which are associated with skin cancers and burns.

SPF 15 blocks 93 percent of UVB rays, while SPF 30 and SPF 50 block 97 and 98 percent of UVB rays, respectively, helping to prevent skin cancer. Which is why the FDA is still encouraging sunscreen users to continue using skin protectants as the rulemaking process continues.

Lastly, the FDA wants to make it mandatory for sunscreen manufacturers to clearly label their products with active ingredients on the front, as well as more clear formats for SPF, broad-spectrum and water-resistant statements.

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