Commentary

Sunscreen Regulations and Advice for Your Patients

Cutis. 2019 May;103(05):251-253

References

FDA advances new proposed regulation to make sure that sunscreens are safe and effective [news release]. Silver Spring, MD: US Food and Drug Administration; February 21, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631736.htm. Accessed April 4, 2019.
Sunscreen drug products for over-the-counter human use. Fed Registr. 2019;84(38):6204-6275. To be codified at 21 CFR §201, 310, 347, and 352.
Sunscreen drug products for over-the-counter human use. Fed Registr. 1978;43(166):38206-38269. To be codified at 21 CFR §352.
Sunscreen drug products for over-the-counter human use; amendment to the tentative final monograph. Fed Registr. 1996;60(180):48645-48655. To be codified at 21 CFR §352.
Sunscreen drug products for over-the-counter human use; amendment to the tentative final monograph; enforcement policy. Fed Registr. 1998;63(204):56584-56589. To be codified at 21 CFR §352.
Sunscreen drug products for over-the-counter human use; final monograph. Fed Registr. 1999;64(98):27666-27693. To be codified at 21 CFR §310, 352, 700, and 740.
Sunscreen drug products for over-the-counter human use; final monograph; partial stay; final rule. Fed Registr. 2001;66:67485-67487. To be codified at 21 CFR §352.
Sunscreen drug products for over-the-counter human use; proposed amendment of final monograph. Fed Registr. 2007;72(165):49069-49122. To be codified at 21 CFR §347 and 352.
Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. Fed Registr. 2011;76(117):35619-35665. To be codified at 21 CFR §201 and 310.
Sunscreen Innovation Act, S 2141, 113th Cong, 2nd Sess (2014).
Nonprescription sunscreen drug products-safety and effectiveness data; guidance for industry; availability. Fed Registr. 2016;81(226):84594-84595.
Statement from Commissioner Scott Gottlieb, MD, on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens [news release]. Silver Spring, MD: US Food and Drug Administration; May 22, 2018. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm608499.htm. Accessed April 5, 2019.

If by now you have not had a patient ask, “Doctor, what sunscreen should I use NOW?” you will soon.

The US Food and Drug Administration (FDA) recently published a press release detailing a proposed rule on how manufacturers will be required to test and label sunscreens in the United States.^1,2 Although the press release was complicated and contained much information, the media specifically latched onto the FDA’s consideration of only 2 active sunscreen ingredients—zinc oxide and titanium dioxide—as generally recognized as safe and effective (GRASE). In response, some patients may assume that most sunscreens on the market are dangerous.

How did this new proposed rule come about? To understand the process, it takes some explanation of the history of the FDA’s regulation of sunscreens.

How are sunscreens regulated by the FDA?

The regulatory process for sunscreens in the United States is complicated. The FDA regulates sunscreens as over-the-counter (OTC) drugs rather than as cosmetics, which is how they are regulated in most of the rest of the world.

The US sunscreen regulation process began in 1978 with an advance notice of proposed rulemaking from the FDA that included recommendations from an advisory review panel on the safe and effective use of OTC sunscreen products.³ At that time, 21 active sunscreen ingredients and their maximum use concentrations were listed and determined to be safe, or GRASE. It also gave manufacturers guidance on how to test for efficacy with the methodology for determining the sun protection factor (SPF) as well as various labeling requirements. Over the years, the FDA has issued a number of other sunscreen guidelines, such as removing padimate A and adding avobenzone and zinc oxide to the list of GRASE ingredients in the 1990s.^4,5

In 1999, the FDA issued a final rule that listed 16 active sunscreen ingredients and concentrations as GRASE.⁶ There were some restrictions as to certain combinations of ingredients that could not be used in a finished product. Labeling requirements, including a maximum SPF of 30, also were put in place. This final rule established a final sunscreen monograph that was supposed to have been effective by 2002; however, in 2001 the agency delayed the effective date indefinitely because they had not yet established broad-spectrum (UVA) protection testing and labeling.⁷

The FDA published a proposed rule in 2007 as well as a final rule in 2011 that again listed the same 16 ingredients as GRASE and specified labeling and testing methods for establishing SPF, broad-spectrum protection, and water-resistance claims.^8,9 The final rule limited product labels to a maximum SPF of 50+; provided directions for use with regard to other labeling elements (eg, warnings); and identified specific claims that would not be allowed on product labels, such as “waterproof” and “all-day protection.”⁹

Nevertheless, an effective final OTC monograph for sunscreen products has not yet been published.

Sunscreen Regulations and Advice for Your Patients

References

How are sunscreens regulated by the FDA?

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