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Regulation

FDA proposes changes to US sunscreen rules

Agency clarifies which ingredients need additional safety, efficacy data

by Britt Erickson
February 21, 2019

 

The US Food and Drug Administration is seeking data to show that certain ingredients found in sunscreens sold in the US are safe and effective. The agency is also looking to expand the range of ultraviolet light that sunscreens block.

Under a rule proposed by the FDA on Feb. 21, manufacturers would need to provide FDA with safety data if their products contain any of the following 12 chemicals: avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone, padimate O, and sulisobenzone.

FDA’s proposed sunscreen rules at a glance

Generally recognized as safe and effective (GRASE):

Zinc oxide and titanium dioxide

Sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks

Not GRASE:

Para-aminobenzoic acid (PABA) and trolamine salicylate; products that combine sunscreens with insect repellents

Wipes, towelettes, body washes, and shampoos

Insufficient data to determine GRASE status:

Avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone, padimate O, and sulisobenzone

Powders

For SPF 15 and higher, broad spectrum UVA protection required.

“This request for additional data does not mean that FDA has concluded that these 12 ingredients are unsafe,” says Theresa Michele, director of FDA’s Division of Nonprescription Drug Products. Rather, the agency is requesting such data so that it can evaluate whether the chemicals are generally recognized as safe and effective (GRASE).

The FDA needs such data so it can finalize what is called an over-the-counter (OTC) monograph for sunscreens by Nov. 29, the deadline set by the 2014 Sunscreen Innovation Act. The monograph is a set of standards under which certain OTC drugs can be marketed without new drug applications because they are GRASE.

The agency is proposing to categorize zinc oxide and titanium dioxide GRASE without additional data.

The FDA is also proposing to deem para-aminobenzoic acid (PABA) and trolamine salicylate—two chemicals no longer used in sunscreens sold in the US—not GRASE because of safety concerns.

The FDA also investigated various forms of sunscreens. The agency is proposing to classify oils, lotions, creams, gels, butters, pastes, ointments and sticks GRASE. Sunscreen sprays would also be GRASE but with particle-size restrictions to minimize health risks from inhalation. The agency is asking for additional data for powders to evaluate whether such products can be considered GRASE. The FDA is proposing that wipes, towelettes, body washes, and shampoos are not GRASE.

One of the most significant parts of the proposed rule is a provision that would require broad-spectrum UVA and UVB protection in sunscreens with a sun-protection factor (SPF) of 15 or higher, Michele says. SPF indicates the ability of a sunscreen to block UVB rays, which have wavelengths of 290–320 nm. The FDA wants to ensure that consumers are also protected against UVA rays, which have wavelengths of 320–400 nm and penetrate the skin more deeply than UVB. The agency is proposing to require UVA protection in sunscreens to increase proportionally with increasing SPF.

The Environmental Working Group, an advocacy organization, called the FDA’s proposal a big win for public health. “For a decade, EWG has worked to raise concerns about sunscreens with oxybenzone, which is found in nearly all Americans, detected in breast milk and potentially causing endocrine disruption,” David Andrews, a senior scientist at EWG, said in a statement. “If the FDA’s proposed changes are adopted, American consumers should be able to navigate the sunscreen aisle and choose better and more effective products for themselves and their families.”


CORRECTION: This story was updated on March 12, 2019, to correct an editing error that led to incorrect wavelengths for UVA and UVB rays.


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Comments
Ian (March 5, 2019 1:13 PM)
I think they mixed up the wavelengths of UVA and UVB rays. UVA rays have wavelengths of 400-320nm and UVB have wavelengths of 320-290 nm.

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