Sunscreen safety: FDA details new ingredient and label changes

Chris Davies - Sep 24, 2021, 12:08pm CDT
Sunscreen safety: FDA details new ingredient and label changes

Baz Luhrmann may have been convinced by the benefits of sunscreen, but the US FDA is weighing in with new potential changes to how sunblock is formulated and labeled. The proposed revisions and updates focus on ensuring the active ingredients in sunscreen are sufficient – and safe – and that product packaging is clear and not misleading.

“In the short term, these new authorities essentially preserve status quo marketing conditions for these sunscreens,” the US Food and Drug Administration said in a statement today. “However, the agency today proposed revisions and updates to those requirements related to maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements, and product labeling, among other provisions.”

The FDA’s role in regulating how sunscreen is formulated and labeled has become a complex one, building on several generations of prior rules. Most recently, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020. That included updates for sunscreen regulations and testing, along with other over-the-counter drugs.

These new rules being proposed are based, for the most part, on the existing 2019 regulations. However, there are a few key differences. Perhaps the most obvious in stores will be the maximum SPF value that sunscreens can claim. Currently, there’s no maximum, but the FDA is proposing “SPF 60+” as a limit. That could, though, cover sunscreens actually formulated up to SPF 80 in the bottle.

As for what’s inside that bottle specifically, the new final order would also address that. Currently, a process known as GRASE – or “generally recognized as safe and effective” – is followed, where manufacturers of certain OTC drugs can market their products even without getting a new FDA application approved.

16 different active sunscreen ingredients would be considered GRASE, according to the new proposal. That would now include zinc oxide and titanium dioxide, at concentrations of up to 25-percent. However, sunscreens containing aminobenzoic acid (PABA) and trolamine salicylate would not be considered GRASE given evidence suggesting they are not safe.

The FDA wants more information on sunscreens containing cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone, to demonstrate GRASE.

Perhaps confusingly, that doesn’t mean the FDA is saying that sunscreens that use those active ingredients aren’t, in fact, safe for people to use. “Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions,” the agency explains, “including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”

Sunscreens that have not been shown to help prevent skin cancer, or indeed early skin aging caused by the sun, would be required to include a “Skin Cancer/Skin Aging alert” on the packaging. The FDA is also tweaking how the SPF level, broad spectrum, and water resistance statements be shown, to improve clarity.

While it may not see any existing sunscreens removed from store shelves, it does mean that manufacturers who want to market those products with non-GRASE ingredients will need to supply the FDA with new safety data if they want to carry on selling their products. A final rule is still some way out; the CARES Act specifies that the revised final order’s effective date must not be earlier than one year after its issuance.


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