PracticalDermatology

Are sunscreens safe? Are they effective? These questions likely are top of mind for your patients, and recent developments and their associated media coverage have only served to muddy the waters.

Dermatologists—who are attentive to the science and knowledgeable about regulatory processes—know that the answer to both of these questions is generally yes. However, we also recognize that sunscreens are not the sole tool in a comprehensive UV protection strategy. It is essential to answer patients’ questions and set them on a path toward healthy skin. Here’s an update on some key developments with analysis of their implications.

Some Sunscreen Ingredients will Get More Study

The FDA this fall released a final order regarding its requirements for OTC distribution of sunscreens. The action came as part of a provision of the 2020 CARES Act, which did not change the scientific standards for determining whether a sunscreen may be legally marketed without an approved application. As acknowledged by FDA, the deemed final order essentially preserves the pre-CARES Act status quo marketing conditions for sunscreens. It incorporates aspects of a 1991 final monograph regulation for OTC sunscreen products (that never took effect) and a final 2011 labeling and effectiveness testing rule.

The FDA already had indicated in 2019 that 12 sunscreen ingredients had “insufficient safety data to make a positive GRASE [generally recognized as safe and effective] determination at this time.” According to FDA, two ingredients—zinc oxide and titanium dioxide—are GRASE, and two other ingredients—PABA and trolamine salicylate—are not GRASE.

To be clear, FDA is not saying those 12 ingredients are not safe. Rather, GRASE is a regulatory term, and products not in the GRASE category may require individual review and approval in order to be brought to market.

Bottom Line: Patients can be assured that sunscreen ingredients on the US market currently have not been shown to induce any injury with years of use by millions of consumers. Those who are still concerned can reach for products containing zinc oxide and titanium dioxide, which are GRASE.

Sunscreen Efficacy May be Lacking

The controversial Environmental Working Group (EWG) recently published data showing that many sunscreens may not provide the level of protection against UVB that their SPF values would indicate. In fact, researchers report that many sunscreens offered just 42 to 59 percent of their stated UVB screening effect. (Photodermatol Photoimmunol Photomed. 2021 Oct 3. E-pub)

The same researchers attempted to correlate UVA filtering with SPF. Strictly speaking, this is not an expected point of comparison, since SPF is a measure of UVB filtering. However, FDA has yet to establish a rating system for UVA filtering. The team found that, on average, the UVA filtering of sunscreens roughly correlated with 24 percent of a formulation’s UVB filtering. Notably, all tests were performed in a lab setting and not on live subjects.

Bottom Line: Sunscreens are not perfect. Some brands may be more reliable than others (but don’t assume higher price assures quality). There is also potential variability in sunscreen performance based on formulation type. For example, sprays may be difficult to apply evenly in the real world. Furthermore, a sunscreen is only beneficial when used properly. Patients may not apply a sufficient amount of sunscreen to achieve protection and they may not reapply as needed.

Patients require education about selection and proper use/application of sunscreens. They also need education that sunscreen is just one part of a comprehensive UV avoidance strategy that includes limiting exposure to the sun at midday and using sun-protective clothing, including apparel with a UPF or UV Protection Factor rating.

More Young People Need to be UV Safe

The proportion of teens who rarely or never use sunscreen has climbed to the highest percentage in 18 years. According to the Youth Risk Behavior Surveillance System, 15.5 percent of high school students rarely or never wear sunscreen SPF 15 or higher when spending more than an hour outdoors on a sunny day. This is up from a low of nine percent in 2005 and the previous high of 14.7 in 2001. Thankfully, the percentage of students who have used an indoor tanning device has dropped significantly from 15.6 percent in 2009 to 4.5 percent in 2019, according to the same survey.

Bottom Line: Damage to the skin early in life is a key risk factor for skin cancers later in life. Establishing healthy UV avoidance habits in early life is essential for long-term skin health. The ASDS’s Sunucate program has led to young people in more than half of the states in US having access to sunscreen in school and while at camps.

Additionally, the newly launched SunHero program (beasunhero.com), which I launched in partnership with CeraVe and La Roche-Posay, is making it easy to bring UV safety education into schools across the country. As part of the program, dermatologists have access to a curriculum intended to teach sun safety to kids. The program provides a sun safety kit for each child, including sunscreen samples, Sun Hero branded swag, and more. Interested dermatologists can visit the site for more details and guidance on how to get involved with local schools, sports clubs, camps, and civic organizations to increase UV safety education for young people.