New sunscreen labeling represents step forward in improving photoprotection

February 1, 2012

Implementation of the final regulations from the Food and Drug Administration for sunscreen testing and labeling should enable consumer selection of effective sunscreen products. More work is still needed, however, to better educate the public about the damaging effects of UV exposure and to motivate appropriate sunscreen use, says Vincent A. DeLeo, M.D.

Key Points

Las Vegas - Implementation of the final regulations from the Food and Drug Administration for sunscreen testing and labeling should enable consumer selection of effective sunscreen products. More work is still needed, however, to better educate the public about the damaging effects of UV exposure and to motivate appropriate sunscreen use, says Vincent A. DeLeo, M.D.

Dr. DeLeo, chairman, department of dermatology, St. Luke's/Roosevelt Hospital Center, Beth Israel Medical Center, New York, provided an update of the latest information on sunscreens during the 30th Fall Clinical Dermatology Conference.

In June 2011, the FDA issued final rules on sunscreen labeling and testing that will take effect in 12 to 18 months. According to the new monograph, the only number that will appear on the label of sunscreen products will be for the SPF (sun protection factor), and currently, the regulations propose that the highest value allowed will be 50+. Labeling with a higher number may be allowed, however, if industry can validate products with higher SPF values provide increased efficacy.

To give users some idea of how long they can stay in the water and maintain the labeled SPF protection, products will be labeled with one of two ratings - water resistant (40 minutes) or water resistant (80 minutes). The terms waterproof, very water resistant, sweat-proof or all-day protection will not be allowed, nor will the term sunblock.

Products with an SPF greater than or equal to 15 and meeting the testing criteria to determine UVA protection will be labeled as "broad-spectrum." UVA protection will be determined based on a single test for measuring critical wavelength, which is the wavelength in the testing paradigm at which the sunscreen absorbs 90 percent of all UV radiation. Products must have a critical wavelength of 370 nm or higher to be considered as providing adequate UVA protection.

The labeling of broad-spectrum products will be allowed to state, "This product helps to prevent skin cancer and early skin aging in addition to sunburn."

Products that are not broad-spectrum and/or do not have an SPF of 15 or greater will need to include the following skin cancer/skin aging alert on their label: "Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging."

"In the past, the FDA has not allowed sunscreens to make claims about carcinogenicity or about photoaging. The fact that they will be able to is good for consumers who are choosing sunscreens and for physicians talking about sunscreens with their patients," Dr. DeLeo says.

In reviewing data from studies investigating skin cancer risk behavior, Dr. DeLeo mentioned a relatively recent article (Bandi P, Cokkinides VE, Weinstock MA, Ward E. Pediatr Dermatol. 2010;27(1):9-18) that had mixed news. The paper compared findings from two surveys of adolescents conducted in 1998 and 2004 and showed use of sunscreen, hats and sun-protective behavior had increased over time. Between 1998 and 2004, however, there was also an increase in indoor tanning among adolescents, while the prevalence of sunburns was unchanged. "In both survey periods, nearly half of all the participants reported having at least one sunburn in the last year," he says.

Other studies show that even when sunscreens are used, the amount applied may be only 25 to 75 percent of that necessary to achieve the product's labeled protection. Results of one recently published study suggest that cost may be an explanation for underuse (Mahé E, Beauchet A, de Maleissye M-F, Saiag P. J Am Acad Dermatol. 2011;65(3):e73-e79). The analyses showed that a family of four vacationing at the beach for one week would need to spend up to $240 on sunscreen for appropriate coverage. The cost could be reduced significantly by wearing sun-protective clothing to reduce the area of exposed skin (-33 percent) or by using more economical, larger volume bottles (-41 percent), Dr. DeLeo says.