Is FDA Doing Enough to Make Sure Sunscreens are Safe?

Is FDA Doing Enough to Make Sure Sunscreens are Safe?
National Center for Health Research Statement in Response to FDA Proposed Regulations
February 22, 2019

 The National Center for Health Research (NCHR) supports the FDA’s proposed new regulations for over-the-counter (OTC) sunscreens. The proposed updates on how products are labeled should make it easier for consumers to identify key product and ingredient information.  Expanding the requirements for broad spectrum protection is an important safeguard, because it provides better protection against damaging UVA radiation.

FDA has found two ingredients commonly used in sunscreens, zinc oxide and titanium dioxide, to be GRASE (Generally Recognized as Safe and Effective) and found two others, . PABA and trolamine salicylate to be not GRASE. The latter two were previously removed from sunscreens so that decision has no impact.  We are disappointed that the FDA has not recognized a widely used sunscreen ingredient, oxybenzone, as unsafe.  Oxybenzone has been found to disrupt hormones, and could increase the risk of endometriosis in women, and alters sperm in animals.  For those reasons, NCHR recommended in 2016 that this ingredient be banned from sunscreen products.

FDA’s proposed rule admits that “there is potential for toxicity associated with the transdermal absorption and systemic availability of oxybenzone.”  However, the proposed regulation states that “This new information about absorption and potential safety risks is inadequate, by itself, to support an affirmative conclusion that products containing the active ingredients at issue are not safe”.  NCHR strongly encourages FDA to require research as soon as possible if the companies plan to continue using it.

Sunscreens are proven to prevent sunburn and since sunburn increases the risk of skin cancer, sunscreens are assumed to also reduce the risk of skin cancer.  Since that link isn’t proven, the role of FDA in ensuring these products are safe is absolutely essential.  As we did in 2016, NCHR strongly urges that FDA expedite the adoption of the proposed rule’s safety and efficacy measures for sunscreens, and immediately require research on other sunscreen ingredients for which the agency has insufficient information.

If you have any questions, please contact Jack Mitchell at