FDA Questions Sunscreen Safety

The US Food and Drug Administration (FDA) took steps this past week toward improving the quality, safety, and efficacy of sunscreens as part of new authorities for certain over-the-counter (OTC) drugs.

In the short term, how sunscreens are marketed won’t change much. The new authority essentially maintains the status quo as outlined in the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act, but a proposed order could have a huge impact long term.

The FDA’s proposed order would change requirements related to maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements, and product labeling. It would also reevaluate what active ingredients are generally recognized as safe and effective (GRASE).

Proposed Labeling Changes

  • SPF 60+ would be the maximum labeled SPF.
  • An alphabetical list of the active ingredients would have to be prominently displayed.
  • A “Skin Cancer/Skin Aging alert” on packaging would be required for sunscreen products that have not been shown to help prevent skin cancer or early skin aging from the sun

Broad Spectrum Protection

All sunscreens with SPF values of 15 and above must provide broad spectrum protection. This designates that the product blocks both UVA and UVB rays.

GRASE Status

OTC drugs with active ingredients that are deemed generally recognized as safe and effective (GRASE) can be marketed without new drug approval. The CARES Act expanded the GRASE list for sunscreen active ingredients to 16. The FDA proposal identifies 12 sunscreen ingredients that it would like to see additional safety and efficacy data on. Mineral ingredients zinc oxide and titanium dioxide would maintain GRASE status.

The FDA emphasizes that any new sunscreen requirements will take over a year to be implemented. The proposed order must go through a 45-day public comment period. Then, at least a year must past before the revised final order can take effect as specified by the CARES Act.