The Sunscreen Filter
actually hits the user.
2. The Monograph states to apply“fif-teen minutes before sun exposure,”
yet this product is typically used as an
easily applicable product that is
sprayed on at the beach, pool, etc.
3. Data should be supplied showing the
product is equally effective if rubbed
or sprayed. For example, the FDA is
suggesting labeling that instructs the
consumer to spray in the hand and
then rub on the face.
How do SPFs vary when a user does
not apply as much as used in the laboratory
tests? Dr. Olga Dueva-Kogonov will offer
insights and recent data concerning sprays.
Sprays are no different than lotions and
creams where every study ever performed
shows consumers do not use enough prod-
uct. If it is known that for accepted dosage
forms of lotions and creams are not applied
and used correctly, why should sprays be
held to a different and more rigorous stan-
dard? Also, sprays hold about a 30% mar-
ket share in the US mass market sun care
arena. It is obvious that sprays enjoy a
tremendous following from consumers. It
is unreasonable for the FDA to not allow
this dosage form and risk alienating con-
sumers. This could only exacerbate the real
problem with sun care users do not use
sunscreen often enough.