Day Spa Magazine
June 5, 2013
Regardless of the extent of awareness now surrounding the importance of sun protection, melanoma rates climbed drastically from 1970 to 2009—increasing by 800% among young women and 400% among young men, according to the Public Access to Sunscreens (PASS) Coalition—which makes it more common than all other cancers combined. Hence, it has never been more crucial for spa professionals to understand the latest regulatory policies regarding the labeling of SPF products and inform clients about sun protection today—and of course to become first-line responders by screening for early signs of skin cancer.
The Regulatory Story
The U.S. Food and Drug Administration (FDA) recommends that consumers use sunscreen products to reduce the risk of various types of sun-induced skin damage, including sunburn, skin cancer and early signs of aging. According to the organization, sunburn is primarily caused by ultraviolet B (UVB) radiation, but officials note that skin cancer and early skin aging are caused by both UVB and ultraviolet A (UVA) radiation. In recent years, the FDA has increasingly taken both of these forces into account to establish new sunscreen testing and labeling requirements, designed to help consumers make more informed decisions about their sunscreen products.
Hensin Tsao, associate professor of dermatology at Harvard University and clinical director of Massachusetts General Hospital’s Melanoma & Pigmented Lesion Center in Boston, explains that the first generation of sunscreens focused on UVB, because that wavelength is what causes visible effects—i.e., sunburn. But then, scientists realized that UVA actually penetrates deeper, having damaging effects that scientists still don’t fully understand but that generally lead to oxidative damage, the altering of collagen and elastin, wrinkling and photo damage. “As more studies suggested that the combination of UVA and UVB is what promotes cancer, the next generation of sunscreens were designed to target UVA as well,” says Tsao.
To help determine a sunscreen product’s ability to assist in reducing sun-induced skin damage, the FDA has established two efficacy tests: the SPF Test (see Understanding SPF, below), which measures the level of sunburn protection provided by the sunscreen product (i.e., UVB protection only); and the Broad-Spectrum Test, which measures the UV absorbency of the sunscreen product across UVB and UVA wavelengths.
“All sunscreen products need to be labeled with the SPF value as determined by the SPF Test, and all sunscreen products are allowed to label themselves with a claim for helping to prevent sunburn based on this test,” notes Lisa Kubaska, spokesperson for the FDA’s Center for Drug Evaluation and Research. “However, only products that pass the Broad-Spectrum Test can be additionally labeled as ‘broad-spectrum’ and, the broad-spectrum term and SPF value must appear as continuous text [e.g., ‘Broad-Spectrum SPF 15’].”
The FDA further states that only products that are broad-spectrum SPF 15 or higher are allowed a claim for decreasing the risk of sun-induced skin cancer and early skin aging—if used as directed with other sun protection measures, which include avoiding the midday sun and wearing protective clothing.
Another longstanding concern of the FDA concerns the labeling surrounding a product’s water-resistance. Hence, 2011’s Water-Resistance Test. The Water-Resistance Test is a modification of the SPF Test; it requires test subjects to apply the sunscreen product, and then immerse themselves in a tub of water for either 40 or 80 minutes, after which they’re exposed to doses of UV. Products tested according to the water-resistance test may be labeled as water-resistant (40 minutes) or water-resistant (80 minutes), depending on whether they were tested using the stipulated 40- or 80-minute water immersion times.
Tsao mentions another recent development in the world of SPF: the motion afoot to cap SPF at 50. The FDA has indeed proposed labeling that limits products to a “50+” SPF. “We lacked data demonstrating that products with SPFs higher than 50 provided any additional benefit compared to products with SPFs of 50,” explains Kubaska. The organization is currently evaluating its data but, until the proposal is finalized, sunscreen products with SPFs higher than 50 are allowed to market “under FDA’s enforcement discretion,” says Kubaska.
And what’s the state of common sunscreen ingredients’ safety? While the FDA is continually evaluating the safety of sunscreens, currently it is “not aware of any data demonstrating that the active ingredients in currently marketed OTC sunscreen products pose any safety hazard to consumers,” says Kubaska, who adds, “We will continue to evaluate the safety of sunscreens’ active ingredients according to current standards of drug safety testing as part of our ongoing review of the OTC Monograph for sunscreen drug products.”
Raising the Shield
A first step in helping spa clients protect themselves against the effects of aging (as well as more serious complications such as skin cancer) is to inform them about the critical and proper use of sun protection, with an emphasis on reapplication. Many spa pros cap massage and facial sessions with some wise words of cautionary wisdom.
“I tell patients to reapply at least every two hours, because many people think they can put on SPF 50 in the morning and they’re fine for the entire day,” says Tsao. “But after a few hours, a sunscreen that’s SPF 100 will go down to SPF 5!” He adds that clients often buy one tube or spray to last the entire summer, when they should actually be using a tube in a week or less; total body coverage requires about three grams of product.
Any delivery system—gel, cream, ointment, etc.—can be effective; the right formula is simply the one that your client will be most apt to reapply every couple of hours, says Tsao. “An SPF 30 that is broad-spectrum and water-resistant should do the job, since an SPF of 15 to 30 blocks 96% to 98% of sun damage.”
In addition to providing clients with general education, estheticians and other spa employees can literally save lives by checking skin for signs of abnormalities during services. To honor the role that beauty professionals can play in early detection, The Melanoma Foundation of New England (MFNE), based in Concord, Massachusetts, launched a program this spring called The Skinny On Skin, which educates pros on how to identify suspicious moles on areas that clients can’t readily see, such as on the scalp, neck and back. (The MFNE reports that although only 10% of melanoma occurs on the neck and scalp, these instances account for a large portion of all melanoma deaths, as they often go undetected or are caught late.)
And, since spa professionals see their clients, on average, every few weeks (more often than most people visit doctors), and are familiar with their clients’ skin, they’re in the unique position to spot potential melanoma long before anyone else. “Even dermatologists might not examine the scalp for melanoma, which can be easier to see when the hair is wet,” explains Deb Girard, executive director of MFNE. “With basic training, beauty and spa professionals can learn how to talk with clients about anything that is new or evolving. Pros and their employees can be great partners in the quest to raise awareness.” The ultimate goals of the program: To increase the frequency with which pros look for dangerous signs (using the “ABCDE” guidelines), to deliver “safe sun” messages, and to foster greater awareness of melanoma.
The Public Access to Sunscreens (PASS) Coalition was formed this year as a “multi-stakeholder coalition of health organizations, sunscreen ingredient companies, dermatologists and citizens who are working with the Food and Drug Administration (FDA), the White House, Congress, healthcare providers, consumer organizations and sunscreen manufacturers to establish a framework for approval of the next generation of UV light active filters for over-the-counter sunscreens.”
While many consumers might assume that sunscreen technology is improving rapidly, the coalition reports that the last time the FDA approved a new sunscreen ingredient was in the 1990s—but that outside of the United States, a new generation of photo-stable, broad-spectrum sunscreens that offer UVA and UVB protection have been approved for use. And, since 2002, there have been eight pending sunscreen ingredient applications that are still awaiting approval from the FDA.
“Since the time and extent application [TEA] process was established in 2002, no new ingredients have been approved, so we’re trying to understand why—is it a resource or data issue? What are the holdups?” reports Al Pearce, senior marketing manager of personal care North America for BASF Corporation, a chemical company in Florham Park, New Jersey.
“One such ingredient approved for use in other countries is bemotrizinol, which offers broad-spectrum protection and allows products to attain a high level of SPF,” Pearce says. He advises concerned spa owners and clients to visit the PASS Coalition website to learn how to contact congresspeople and senators, and express concern.
SPF measures how long it takes for the skin to develop redness versus how long it would take without sunscreen, explains Hensin Tsao, associate professor of dermatology at Harvard University and clinical director of Massachusetts General Hospital’s Melanoma & Pigmented Lesion Center in Boston. For example, if it takes three times longer, the SPF is 3.
“SPF is a measure of this ratio—a measurement of blocking sunburn,” Tsao says. “But there is no measure of UVA, so most are determined by how much of a compound in a test tube is absorbed to estimate UVA protection.” Some ingredients that are known to absorb UVA are avobenzone and Mexoryl from La Roche-Posay; there aren’t many UVA-absorbing compounds yet, but to prove broad-spectrum protection, companies must show that the product protects against both.
Tsao adds that because there has been some “wild labeling” of SPF products in the past, he considers the new labeling rules from the FDA incredibly important for consumers.
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