By Jan Bowers, contributing writer, June 01, 2012
With new federal rules for sunscreens set to take effect at the end of 2012, consumers stocking up this summer will, for the first time, see some products that meet specific criteria for broad-spectrum UV protection. Manufacturers will soon be required to scrap labels with misleading terms that overstate a product’s capabilities, such as “waterproof” and “sunblock.” And dermatologists will finally be able to provide their patients with simple, clear instructions for selecting and using sun-protection products safely and effectively.
The new rules, announced by the U.S. Food and Drug Administration (FDA) in June 2011 and discussed in last September’s issue of Dermatology World (“Broad Spectrum Protection,” p. 18), create a broad-spectrum designation and limit the claims sunscreens can make. They also allow certain sunscreens to claim they reduce the risk of skin cancer and early skin aging, eliminate the terms waterproof, sweatproof, and sunblock from labels, and allow water-resistance claims to be made for only time-limited periods. (See sidebar, "Label changes," for details.)
New parameters for “broad spectrum”
“Up until now, the meaning of broad spectrum’ on the label could vary tremendously; there was no definition as to what test needed to be done for a sunscreen product to qualify for the designation of broad spectrum,’” said Henry W. Lim, MD, chair of the department of dermatology at Henry Ford Hospital and immediate past chair of the Academy’s Council on Science and Research. “The FDA finally decided that it would use the in vitro critical wavelength method as a way to determine the level of UVA protectiveness. For a sunscreen to fulfill a broad-spectrum test, the critical wavelength has to be 370 nm or greater, meaning that 90 percent of the absorption has to be between 290 and 370 nm.”[pagebreak]
In addition to passing the critical wavelength test for UVA protection, a sunscreen must have an SPF of 15 or higher in order to carry the designation “broad spectrum” on its label. “You have to have balance, what’s called proportionality, of UVA to UVB protection,” said Darrell Rigel, MD, clinical professor of dermatology at New York University Medical Center. “As the SPF protection goes up, you have to proportionately raise the UVA protection.” In its published final rule, the FDA states that “this proportionality between UVB and UVA protection is important because consumers have been accustomed to basing their purchase decision concerning protection level primarily on the SPF value, and only secondarily on indications of whether or not the sunscreen provides broad-spectrum protection.”
“To me, the key difference is that we’ll be able to tell our patients three simple things to look for on the bottle,” Dr. Rigel said. “First, an SPF rating of 30 or higher that’s the Academy’s recommendation, and I agree. Second, it must have the words broad spectrum,’ on the label, because that means it has the proportional UVA protection. And third, look for water resistance of 80 minutes.”
Sunscreen products manufactured and shipped prior to Dec. 17, with the older labeling, can still be sold, Dr. Lim noted. (The FDA announced on May 11 that it would give manufacturers six more months to comply, delaying the original June 18 compliance deadline in response to requests from both the Personal Care Products Council and the Consumer Healthcare Products Association.) “There will be a transition period in which there will be products labeled broad spectrum’ that have fulfilled the requirements of the new rule, and others that say broad spectrum’ but are based on the less rigorous definition. So patients need to read the labels carefully,” Dr. Lim said. Dr. Rigel remarked that “when you start educating people about what to look for, it’s going to make a difference — they may not buy the old stuff. I think this education will change people’s behavior.”
The FDA rule states that if a sunscreen product passes the broad-spectrum test, the product label must include the statement Broad Spectrum SPF [insert numerical SPF value]” without any UVA’’ reference. The FDA is requiring the broad spectrum SPF statement to appear as continuous text with no intervening text or graphics, and that the entire text be the same font style, size, and color on the same background color. In contrast, older labels might still include the term “UVA/UVB protection,” or show the words “broad spectrum” in a different location or font from the SPF number.[pagebreak]
New products launched
How have sunscreen manufacturers responded to the new rules? “Most major companies will just have to re-label their product,” Dr. Rigel predicted. (Manufacturers of products with sales of less than $25,000 per year have an additional year to bring those products into compliance.) Indeed, two leading providers of sunscreen products maintained that no formulation changes were necessary. Merck Consumer Care (a division of Merck & Co., Inc.), makers of Coppertone products, and Energizer Personal Care, which markets the Banana Boat and Hawaiian Tropic brands, said the majority of their sun care products with SPF 15 and above offer broad-spectrum protection.
“The new products we’re introducing this season were already in the works when the FDA published the final rule last year,” said Patricia Agin, PhD, scientific affairs leader at the Coppertone Solar Research Center. “But certainly as we went forward in finalizing them, we utilized the new FDA testing methodologies to complete our testing prior to launching these products.”
In a proposed rule published along with the final rule last year, the FDA also requested data from industry and others to help determine whether products that are higher than SPF 50 provide a clinical benefit to consumers. But both companies plan to continue to offer products with SPF values below 15 and above 50. Although the FDA has published a proposed rule that would limit the level of SPF that could appear on a sunscreen label to 50, Dr. Agin said, “we feel there are benefits to these products, and there are consumer and patient needs which are addressed by higher SPF products, so we will continue to market them until the FDA makes a decision concerning what the highest level should be.” Raffin said Energizer has collaborated with Johnson & Johnson to propose a testing protocol to the FDA that would support their claim that consumers do benefit from products with SPF greater than 50. (A study recently accepted by the Journal of the American Academy of Dermatology [ePub April 1; doi: 10.1016/j.jaad.2012.02.029], of which Dr. Rigel is a co-author, suggests this claim has merit.)[pagebreak]
Cosmetics and skin care products
Sunscreens aren’t the only products affected by the new FDA rules. Americans spend billions of dollars each year on lipstick, foundations, moisturizers, and other skin care products, many of which contain a sunscreen. “All sunscreen-containing products are considered over-the-counter drugs, and they’re all subject to the same rules,” said Zoe Diana Draelos, MD, consulting professor of dermatology at Duke University and the Academy’s vice president and Council on Communications chair. “Those that meet the criteria for broad-spectrum protection and have an SPF of 15 or higher can now state that their product is anti-aging, based on the fact that it conforms to the new sunscreen guidelines.”
Dr. Draelos predicted that a wave of new cosmetics and skin care products will hit the market with anti-aging claims on the packaging. “We’ll see a lot of moisturizers and foundations that claim to be anti-aging, and I think that’s good,” she said. “But I also think consumers may be a little bit confused because they may not understand that it’s the sunscreen ingredient that’s anti-aging — not some other hocus-pocus that’s in the product. They just need to understand what they’re buying.” Dr. Draelos noted that as the SPF in a product increases, that product tends to become thicker and stickier, and thus less appealing to consumers looking for, say, a sheer foundation. “Everyone will need to pick a product for their specific needs,” she said. “If you’re going to be outside briefly, or driving your car, the foundation or the tinted moisturizer with sunscreen is probably enough, but if you’re going to be swimming, obviously you’re going to need something with water-resistant properties.” Dr. Rigel agreed that for sunscreens, cosmetics, and skin care products, “cosmetic elegance” has a strong bearing on whether consumers will use it or not. “If you give someone really oily, gunky, sticky sunscreen, no one’s going to want to use it — and you can’t tell that from the label,” he said. Dr. Rigel pointed out that the new rules do not apply to sunscreen-containing towlettes, powders, body washes, or shampoos, “so we may start seeing a lot more of those products because they’re not regulated yet.”[pagebreak]
In addition to cosmetic elegance, Dr. Rigel pointed to a couple of other issues that remain unaddressed by the FDA’s sunscreen rules. “One is substantivity the label still doesn’t tell you how long the sunscreen lasts before it breaks down,” he said. “It depends on the formulation, whether you’re swimming or not, and other variables. The label says reapply every two hours,’ but some sunscreens probably don’t require that and others may require it more often.” (A recent AAD survey indicated that only 28 percent of respondents who reported that they “always” or “sometimes” wear sunscreen reapply at least every two hours.) Another issue is the type of container used for the sunscreen. “A study just came out a couple of months ago [Arch Dermatol, ePub Jan. 16; doi:10.1001/archdermatol.2011.2586] looking at that question in kids, and found that they applied the most sunscreen using a spray. The tube was the next best, and the squirt bottle was the worst.”
Because these factors impact a sunscreen’s effectiveness, Dr. Rigel said patients will still look to dermatologists for recommendations. Without expressing a brand preference, he pointed out that the major sunscreen brands may have some cosmetic advantages over generic products. “Two sunscreens can meet the criteria for UV protection, but one of them can be greasy and yucky, and the other one can be really nice and cosmetically elegant,” he pointed out. “You cannot tell from the labeling what that difference is. I think that’s why people will stick with the big brands a little more.”
On the horizon
What will sunscreens of the future look like? Current research is focused on aesthetics and substantivity, said Zoe Diana Draelos, MD, consulting professor of dermatology at Duke University and the Academy’s vice president and Council on Communications chair. “Researchers are working to make zinc oxide and titanium dioxide particles smaller, so they’re not as visible on people with Fitzpatrick types IV, V and VI,” she said. They’re looking for ways to give sunscreen more longevity on the skin, especially in the water. And then the best thing would be oral photoprotection, but that research is very slow, and I don’t think there’s anything close to market.
One advance that may occur in the near term is FDA approval of new UV filters that are currently used in other countries. “There are seven or eight filters that have been around for quite some time in many parts of the world and are now being considered by the FDA through the time and extent application process,” which will allow the FDA to take their prior safe use in other countries into account, said Henry W. Lim, MD, chair of the department of dermatology at Henry Ford Hospital and immediate past chair of the Academy’s Council on Science and Research. That’s an important issue because based on data we have from other countries, these would significantly improve manufacturers’ ability to make better sunscreens than what we have now.” Darrell Rigel, MD, clinical professor of dermatology at New York University Medical Center, noted that “there are now 18 or 19 approved sunscreen agents in the U.S., compared with 28 or 29 in Europe and maybe 42 in Japan.” Drs. Rigel and Draelos both cited Tinosorb, the trade name for a group of UV filters widely marketed outside the U.S., as having specific advantages over filters used in U.S. sunscreens: better photoprotection, particularly in the UVA range, and superior substantivity.
The new sunscreen rules that take effect for large manufacturers on Dec. 17 will make a number of changes to the way products are labeled. Those changes are summarized below.
- Broad-spectrum designation: Sunscreens that pass the FDA’s broad spectrum test procedure, which measures a product’s UVA protection, may be labeled as “Broad Spectrum SPF [value]” on the front label.
- 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 between 2 and 14 can only claim to help prevent sunburn, and must carry a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.
- “Waterproof,” “sweatproof,” or “sunblock” claims: Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness.
- 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 and/or side of the container.