Dermatology community applauds new FDA sunscreen regulations
Labeling requirements aim to make it easier for consumers to select a sunscreen
New sunscreen labeling requirements by the US Food and Drug Administration (FDA) scheduled to go into effect this June should enable consumers to more easily select sunscreens that protect against skin cancer, dermatologists say. “Currently, each sunscreen brand makes its own claims, and one of the things we hear as dermatologists is that the average consumer has no idea what the labels mean,” says Linda Chang, MD, assistant professor of dermatology at the University of Washington in Seattle. “There can be a false sense of security that using a sun ‘block’ means we are protected from sitting out in the sun, or that a higher SPF [sun protection factor] is always better, or that waterproof means it does not need to be reapplied.”
Henry Lim, MD, chair of the department of dermatology at Henry Ford Hospital in Detroit, Michigan, adds, “The new regulations will enable physicians to recommend which type of sunscreens to use and will enable the general public to look for sunscreens that have both good UVB [ultraviolet B] and UVA [ultraviolet A] protection.”
New Look for Labels
The new labels will be standardized, clear, and easy to understand, Dr. Lim notes. Dr. Chang adds that it will also be easier for consumers to compare products, and the labels will provide information on what sunscreens cannot do. In addition, the FDA will more closely scrutinize formulations such as sunscreen powders and body washes that are suspect in terms of the amount of sunscreen that remains individuals after application.
According to the FDA, prior rules concerning sunscreens dealt with protection against sunburn, which is primarily caused by UVB radiation from the sun, and did not address UVA radiation, which contributes to skin cancer and early skin aging. FDA officials have since found sufficient data to establish a “broad-spectrum” test for determining a sunscreen product's UVA protection. Passing the broad-spectrum test indicates that a product provides UVA protection that is proportional to its UVB protection.
As a result, the FDA announced the following new labeling requirements in June 2011:
Broad-spectrum designation. Sunscreens that pass the FDA's broad-spectrum test procedure may be labeled as “Broad Spectrum SPF [value]” on the front label. For these sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad- spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional as described below.
Use claims. Only broad-spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-broad-spectrum sunscreens and broad-spectrum sunscreens with an SPF value of between 2 and 14 can only claim to help prevent sunburn.
“Waterproof,” sweat proof,” or “sunblock” claims. Manufacturers cannot label sunscreens as “waterproof” or “sweat proof” or identify their products as “sunblocks” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (eg, “instant protection”) without submitting data to support these claims and obtaining FDA approval.
Water-resistance claims. Water-resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water-resistant must include a direction instructing consumers to use a water-resistant sunscreen if swimming or sweating.
Drug Facts. All sunscreens must include standard “drug facts” information on the back or side of the container.
In addition, the FDA is considering a proposed rule that would limit the maximum SPF value to “50” because there is not sufficient evidence that products with SPF values higher than 50 provide greater protection than products with SPF values of 50.
Safety and Effectiveness Data Sought
Finally, the agency also is considering data on the effectiveness and safety of spray sunscreens, including the risk of inhalation. “Because sprays are applied in a significantly different manner than other dosage forms, we are requesting data that will demonstrate that this manner of application does not compromise the effectiveness or safety of sunscreen spray products,” says Shelly Burgess, a spokesperson for the FDA.
In addition, recent concerns about the safety of certain sunscreen ingredients have prompted some to question the FDA's oversight in this area, and the agency itself has acknowledged that current ingredients have not been tested for safety using modern techniques. In his blog discussing the new requirements, J. Leonard Lichtenfeld, MD (“Dr Len”), deputy chief medical officer for the American Cancer Society, notes that nanoparticles used in sunscreens, especially those containing zinc and titanium oxides, are still being evaluated for safety.
Burgess says that although the FDA is unaware of any active sunscreen ingredient being unsafe, the agency is evaluating the need for additional safety testing for active sunscreen ingredients.
The new regulations will enable physicians to recommend which type of sunscreens to use and will enable the general public to look for sunscreens that have both good UVB and UVA protection.—Henry Lim, MD
Despite these concerns, the FDA and dermatologists strongly emphasize the importance of using broad- spectrum sunscreens. “From my point of view, the benefits using sunscreen definitely outweigh the risks,” says Dr. He cites recent data from Australian researchers who, after a 12-year study of more than 1600 adults, found that regular use of sunscreen led to a 50% decrease in melanoma and a 73% decrease in invasive melanoma.1
Dr. Lim also is a member of the photobiology committee of the Skin Cancer Foundation, an international organization dedicated to reducing the incidence of skin cancer through a combination of research, public education, and awareness. The voluntary committee evaluates sunscreen products and awards its “Seal of Recommendation” to products that meet its criteria. Last January, in line with the FDA's new requirements, the foundation announced an updated “Seal” that will require scientific verification of the sunscreen's UN/A protection, in addition to the existing UN/B requirement.
Manufacturers whose products meet the new FDA broad-spectrum standards will be allowed to state on the product's label that their sunscreen reduces the risk of skin cancer and early skin aging; however, they also must note that sunscreen needs to be used with other protective measures. Those measures include:
Limiting time in the sun, especially between the hours of 10 am and 2 pm, when the sun's rays are the strongest.
Wearing clothing to cover skin that is exposed to the sun (long-sleeved shirts, pants, sunglasses, and broad- brimmed hats).
Using a water-resistant sunscreen if swimming or sweating.
Reapplying sunscreen, even if it is labeled as water-resistant, at least every 2 hours. (Water-resistant sunscreens should be reapplied more often after swimming or sweating, according to the directions on the label.)
Experts agree that consumers need to be better educated about all sun protection measures. Dr. Lim points out, for example, that many people do not apply enough sunscreen. While the FDA mandate for sunscreen effectiveness testing requires 2 mg per cm2 of body surface area, or approximately 1 ounce for the entire body, most people apply just 0.5 to 0.8 mg per cm2 of body surface area, which is less than one-half the recommended amount.
Consumers need to be aware that limiting sun exposure is the most important factor in skin cancer prevention, says Dr. Chang. Although the FDA will require that sunscreens with SPFs lower than 15 include a warning about the risks of sun exposure, she says the warning actually should be on all sunscreens.