Sunscreen is in the news. The FDA is proposing researchers, manufacturers and consumers take a hard look at how some sunscreens don’t have the data needed to show they’re safe.1 A recently published paper in the Journal of the American Medical Association (JAMA) suggests that active ingredients in commercially available sunscreens quickly enter the bloodstream at levels far exceeding the recommended threshold.2 And, mainstream media and grassroots bloggers are covering the news with headlines suggesting the products consumers trust to protect their skin might be hurting their health.
Through it all, the U.S. Food and Drug Administration (FDA), American Academy of Dermatology, researchers and physicians are urging Americans to continue using sun protection, including sunscreen, until more is known.
It’s a challenging situation for dermatologists, according to Henry W. Lim, M.D., chair emeritus of the department of dermatology at Henry Ford Hospital in Detroit.
“Dermatologists and the public in general have to make sure not to lose sight of the importance of photoprotection. We all know the side effects of UV exposure, and we know photoprotection does decrease the development of skin cancer,” Dr. Lim says. “We need to continue to emphasize that photoprotection is important and sunscreen is one part but not the only part of photoprotection. We also need to continue to emphasize that while the FDA is requesting more data, the FDA has also been very clear that people should continue to use sunscreen. The data that they got on the JAMA article — the clinical significance of that requires further study.”
FDA’S PROPOSED RULE
In late February 2019, the FDA publicly issued its proposed rule — one it calls a significant action to bring nonprescription, over-the-counter sunscreens that have, until now, largely escaped the FDA’s radar under greater scientific scrutiny. The final rule would impact how industry markets sunscreens.
“The agency is issuing this proposed rule to put into effect final monograph regulations for OTC sunscreen drug products as required by the Sunscreen Innovation Act,” according to the FDA. “OTC monographs establish conditions under which the FDA permits certain OTC drugs to be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded.”
ACCORDING TO THE PROPOSED RULE:
Zinc oxide and titanium oxide are the only two of 16 marketed active ingredients, or filters, that are GRASE.
On the other side of the safety spectrum, aminobenzoic acid (PABA) and trolamine salicylate should not be used in sunscreens due to safety issues.
Dr. Laughlin is a shareholder and consultant for The Sunscreen Company (Cyberderm). No disclosures for Dr. Zeichner or Wang. Dr. Lim reports research grants to Henry Ford Hospital from Estee Lauder, Ferndale, Unigen. Dr. Lim is a consultant for Pierre Fabre and ISDIN.
1. Sunscreen Drug Products for Over-the-Counter Human Use. Federal Register Website. https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscree.... Published February 26, 2019. Accessed May 2019.
2. Matta MK, Zusterzeel R, Pilli NR, et al. Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial. JAMA. 2019;
3. Wang J, Pan L, Wu S, et al. Recent Advances on Endocrine Disrupting Effects of UV Filters. Int J Environ Res Public Health. 2016;13(8)
4. Harley KG, Berger KP, Kogut K, et al. Association of phthalates, parabens and phenols found in personal care products with pubertal timing in girls and boys. Hum Reprod. 2019;34(1):109-117.
5. Rehfeld A, Egeberg DL, Almstrup K, Petersen JH, Dissing S, Skakkebæk NE. EDC IMPACT: Chemical UV filters can affect human sperm function in a progesterone-like manner. Endocr Connect. 2018;7(1):16-25.