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FDA Issues New Sunscreen Regulations


The FDA issued new proposed regulations for over-the-counter sunscreens marketed in the United States. These rules update the regulatory requirements for sunscreen to ensure consumers have access to safe and effective sun protective options based on the latest evidence.

“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 have not been updated in decades,” said FDA Commissioner Scott Gottlieb, MD, in a press release.1

Under the new rules, only 2 of 16 active ingredients in sunscreens are “generally recognized as safe and effective” (GRASE)—zinc oxide and titanium dioxide. PABA and trolamine salicylate are not GRASE due to safety issues, while the other 12 ingredients have insufficient data regarding safety and efficacy.


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Other proposals include:

  • Active ingredients in sunscreen should be listed on the front of the package so consumers can identify them easier.

  • Products that have not been proven to help prevent skin cancer should include a notification on the front of the package.

  • Combination sunscreen and insect repellent is not GRASE.

  • The maximum SPF value on sunscreen labels should be raised from 50+ to 60+.

  • Sunscreens with SPF value of 15+ should also provide broad spectrum protection.

  • For broad spectrum products, the degree of protection against UV-A radiation should increase with increases in SPF value.

“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,” said Dr Gottlieb. “The proposal we have put forward would improve quality, safety and efficacy of the sunscreens Americans use every day.”1


FDA advances new proposed regulation to make sure that sunscreens are safe and effective [press release]. Silver Spring, MD: FDA; February 21, 2019. Accessed February 22, 2019.



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