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FDA regulations for sunscreens


Susan Taylor, MD, FAAD, discusses FDA regulations for sunscreens.

Susan Taylor, MD, FAAD: The recent FDA action on sunscreens indicates that all sunscreens with an SPF 15 or higher must satisfy broad spectrum test requirements. This means that the ratio of UV-A1 to UV should be 0.7 or higher. It’s important that all sunscreens have a critical wavelength of 370 nm or higher. The FDA has deemed the maximum labelled SPF of 60 plus and the maximum market SPF of 80.

The FDA has divided sunscreens into 3 categories. Category 1, GRASE, which is generally recognized as safe and effective, are those sunscreens that contain either zinc oxide or titanium dioxide. These are our physical blockers that reflect light. The second category is category 2 or non-GRASE and those are sunscreen ingredients that are no longer allowed, and they include PABA [para-aminobenzoic acid]

and trolamine salicylates. Then, there is a grade three, where the FDA says there’s insufficient evidence of GRASE categorization meaning that there’s not enough studies to say that these chemical sunscreen ingredients are safe and effective.

Trancsript Edited for Clarity

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