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
“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 in-
gredients. 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 suf-
ficiently complete for filing and review and told the audience that
when seeking a meeting with FDA after a Proposed Order, a re-
quest 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
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 in-
gredients to ensure proper protection against UV rays.
For more on the Sunscreen Symposium, visit Happi.com.•
Joe Stanfield of Suncare
Olga Dueva-Koganov of