First the good news—US sun care formulas do a pretty good job of blocking UVB, the sun’s rays that cause erythema. The bad news? The US is in the back of the pack when it comes to reducing the impact of UVA, which may explain the country’s soaring melanoma rates. That’s just one of the facts that came to light during the highly popular Sunscreen Symposium, which was held last month in Orlando, FL. The biannual event, sponsored by the Florida Chapter of the Society of Cosmetic Chemists, attracted more than 400.

But a slow-moving FDA isn’t the only reason why attendees may have been seeing red. Long-time industry consultant John Sottery of IMS suggested that sending Americans out in the sun with today’s FDA-approved products is akin to sending ill-fitted troops into battle. But that’s not just because the Administration refuses to approve the eight actives on the Time and Extent Application (TEA), it’s also because current efficacy guidelines are lacking. Sottery noted that most tests rely on a 2mg dose per square centimeter, a hefty amount that is never used by the typical consumer. Instead, he suggested that researchers reduce the dose to a more likely 1.3mg/cm²—but such a move would reduce protection results.

“Consumers have a false sense of security when the put on sunscreen,” he asserted. “But if sunscreens were tested as they are used in real-life, they would not achieve their label claims.”

He recited study results that suggest most consumers only use 1mg/cm², with students using just .39mg/cm².
“Modern sunscreens are better,” he noted, “but not if people don’t use them.”

Sottery also urged the industry to consider the entire UV spectrum when creating products and not focus solely on the narrow 300-370nm range.

“Current US products that meet the 370nm Critical Wavelength Standard do not provide sufficient protection against tanning, dermal damage, free radical formation, immunosuppression and melanoma and non-melanoma skin cancers,” Sottery charged. “We are selling (products) that have great labels and high numbers, but they don’t work for consumers. They block the erythema but do not provide sufficient UVA1 protection.”

Sottery pointed out that UV rays range from 250 to 2500nm.

“We have to develop products that work in the real world,” he insisted.

Furthermore, today’s formulas block the production of provitamin D3 in the skin and he noted that low vitamin D levels are rampant in the US, although that may be more of a function of living life indoors glued to a cellphone, rather than getting out into the great outdoors. To remedy the vitamin deficiency, Sottery suggested that formulators add vitamin D precursors to their sunscreen products.

Yet, at the end of the day, formulators can only work with the materials approved by FDA; which is why Sottery, and nearly all the speakers during the two-day event, urged FDA to approve the actives that are languishing on the TEA list.
“Give consumers better access to better products,” he concluded.

No Passing Grade
Sottery’s plea was echoed by Olga Dueva-Koganov, who spoke for the Public Access to SunScreens (PASS) Coalition, which represents health organizations, sunscreen manufacturers and consumers in an effort to work with the US government to establish a timely review and approval of new and effective sunscreens. These ingredients—amiloxate, enzacamene, octyl triazone, bemotrizinol, bisoctrizole, iscotrizinol, ecamsule and drometrizole trisiloxane—can already be found in sun care formulas throughout the world—with the exception of the US. For instance, 100% of new sunscreen products launched recently in the EU and Brazil, and 60% of those introduced in Australia contain at least one or more TEA actives. She urged the speedy approval of TEA actives, especially those providing broad spectrum UVB and UVA protection; the allowance of higher usage concentrations of avobenzone (5%), allowance of avobenzone and titanium dioxide concentrations and continuing public education regarding the importance of adequate sun protection.

“Incidence of melanoma is rising 1.9% annually but many cases could be prevented with better sunscreen products,” Dueva-Koganov insisted. “The TEA list is superior to what we currently have; four out of eight of them offer broad spectrum protection. We need more than avobenzone, titanium dioxide and zinc oxide to provide broad spectrum protection.”

Unfortunately, after a presentation by FDA’s Michelle Walker, it doesn’t appear as if industry will have access to these new UV actives any time soon. Walker noted that the goal of the Sunscreen Innovation Act is to provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients. Earlier this year, FDA concluded that industry had not proved that the TEA ingredients were safe and effective. FDA sent letters to manufacturers demanding more data and testing.
Walker called for industry to submit data packages that are sufficiently complete for filing and review and told the audience that when seeking a meeting with FDA after a Proposed Order, a request must be submitted within 30 days of the Proposed Order.
“If the data package is not complete, it may not be filed,” she warned the audience.

For Proposed Orders stating that more information is needed, necessary data must be submitted in order to obtain a GRASE determination. Finally, information supporting a GRASE determination must be publically available.

“Timelines to get new sunscreen ingredients on the market are dependent on industry timelines for data submission,” she concluded.

New Ideas in Testing
Joe Stanfield of Suncare Research Laboratories brought the audience up to date on spin coating, a new technology for sunscreen testing. Stanfield noted that one reason for inaccuracy of in vitro sunscreen test results is the difficulty of creating uniform films on substrates. He suggested that spin coating, which has been used to create thin films for microcircuits, may provide a solution.

When formulas are applied on a rapidly rotating, transparent, flat plate centrifugal and viscous forces spread the sunscreen to a uniform thickness. Stanfield detailed the trials and tribulations of creating the device, and explained how he used fluorescent illumination to evaluate the films. He evaluated several films and was pleased with the results.

“Spin coating provides information on vehicle effects and photostability,” he told the audience. “If the thickness of the film is known, then we can compute the SPF.”

What We Don’t Know
Predicting the future can be a tricky business. When he submitted his abstract to Symposium organizers earlier this year, Julian Hewitt, JPH SunCare Technologies, was quite certain that by the time he approached the podium, the US FDA would approve the eight ingredients on the TEA list. But a not-so-funny, and all-too-familiar thing happened between then and now—absolutely nothing—and the eight actives continue to languish in regulatory limbo.

“FDA approval of TEA sunscreens seems as far away as ever,” he told the audience.

That’s too bad, because it’s a major reason why the US lags so far behind the rest of the world when it comes to UV protection. Furthermore, it makes it next to impossible for multinational marketers to create global formulas, which would reduce costs and simplify supply chains, not to mention make for better products that provide better protection to the world’s consumers. Hewitt noted, for example, that the US has just 16 approved actives (and uses only a handful). In contrast, South African formulators have 53 ingredients at their disposal.

“However, if FDA could be persuaded to increase the maximum avobenzone concentration to 5%, and allow it in combination with ensulizole, titanium dioxide and zinc oxide, this would open up new formulation opportunities,” he insisted.

Hewitt noted that testing regimen for a global formulation has been simplified due to greater harmonization of test procedures. Unfortunately, truly global combination systems are difficult to create due to FDA restrictions and the lack of approval of ZnO in the EU.

“Global formulations can be made using only organic filters, but it is difficult to reach SPF50 and meet all UVA requirements,” he observed. “The simplest approach is to use a single active, in the form of a ‘high UVA’ grade of TiO2.”

But no matter what formulating tricks cosmetic chemists may have up their sleeves, they need a full complement of active ingredients to ensure proper protection against UV rays.

For more on the Sunscreen Symposium, visit Happi.com.