The Sunscreen Filter
THE FOOD AND Drug Administration’s announcement of the Final Rule in June heralded an eventful past few
months in the world of sunscreens. Several
very informative webinars were held including one each from HAPPI (which is
archived on HAPPI.COM and available for
free download), Croda Inc and the Personal
Care Product Council. Also, new academic
findings were reported regarding UVA rays,
tanning salons, caffeine and UV filters from
coral for sunscreen protection. In mid-Sep-tember, the Society of Cosmetic Chemists’
Florida Chapter’s biannual Sunscreen Symposium, not surprisingly, drew a record attendance. This is an exciting time in our
industry; everyone is discussing the proposed new changes.
At the Sunscreen Symposium, a number of informative seminars were presented. The formal presentations at the
Symposium are always interesting, but the
informal discussions that are held in the
hallways and even around the swimming
pools and over dinner are absolutely invaluable. In addition, the tradition of holding a roundtable discussion continued this
& Development Ltd
Dr. Nadim Shaath is the president of
Alpha Research & Development, Ltd. in White Plains,
NY. He has over 30 years of experience as chairman of
the chemistry department at SUNY-Purchase and the
CEO of Kato Worldwide. Recently he formed a consulting company serving the cosmetic industry called
ShaathMeadows Corporation (SMC) with laboratories
in New York, New Jersey, Texas, Florida and Egypt. He
can be reached at firstname.lastname@example.org.
year as well. This
year’s energetic panel
was extremely well organized by Dennis
Lott. The panel included Dr. Reynold
Tan from the FDA,
from L’Oréal, Mike
Brown from Boots
LLC, Joe Stanfield
from Suncare Labs,
from Akzo, Joe Stanton from Dermatest
Australia and me. The
each handled by two
speakers, one arguing
for and one against,
included the following
1. Are in vitro SPF methods viable?
2. Does a critical wavelength of 370nm or
higher provide adequate UVA protection?
3. Should SPF be labeled as tested?
4. Should SPFs be limited by limiting the
amount of sunscreen allowed in a product?
5. Should SPF be capped at 50?
The answers to all those questions, as
well as the abstracts and bios for the speakers are available from the Florida Society of
Dr. Tan, the person in charge of sunscreen regulations at the FDA, participated
in both the Florida Sunscreen Symposium
and the HAPPI webinar. He and I corresponded in a series of emails and telephone
conversations in which he clarified a number of issues that have emerged since the
June 14, 2011 announcement of the Final
In my September column of“The Sunscreen Filter (Vol. 48, No. 9, p. 50),” Dr. Tan
responded to eight questions that were
The FDA has ome issues on how sun protection is applied to skin.
posed to him. In this column, the remaining seven questions are addressed here:
Q. What about pump sprays vs.
aerosols? Are pump sprays “grandfa-
thered” since they have existed for
much longer than aerosols?
A. All OTC drugs must meet standards of
safety and effectiveness. Therefore, no OTC
drug is exempted from meeting safety and
effectiveness standards just because it was
marketed a long time ago (i.e. “grandfa-
thered”). An OTC drug is eligible for inclu-
sion in a monograph if its conditions of use
existed in the OTC drug marketplace on or
before May 11, 1972. Conditions of use in-
clude active ingredient, strength, route of
administration, specific OTC use or indica-
tion of the product, and dosage form (see 21
CFR 330.l4 (a)). We do not know what kinds
of spray dosage forms (pump, aerosol, or
other) were marketed before 1972. Our ad-
vance notice of proposed rulemaking invites
submission of this information, and data
and information pertinent to establishing
safety and effectiveness standards for spray