The Sunscreen Filter
dosage forms in their various
Q. What is the status of the existing inventory that may be at
retail beyond 6/17/2012?
For direct selling companies, can“non-compliant products” that enter the US before
June 18, 2012 be sold until expiration or only until June
A. This question should be directed to the FDA’s Office of
Compliance. This is a question of
when a product is introduced
into interstate commerce. OTC
sunscreen products covered by
the OTC monograph system that
enter interstate commerce as of
June 18, 2012 must comply with
the sunscreen testing and labeling requirements in the 2011
sunscreen final rule.
Some experts insist that a cap of SPF 50 won’t be enough to block the sun’s harmful UV rays.
sun-induced skin damage, particularly sunburn. Therefore, these products are regulated as drugs. Unless
the product is marketed under an approved NDA/ANDA, it is covered by
the regulations for OTC monograph
sunscreen drug products.
Q. Are there any updates on
the dosage form of “wipes” or
A. We do not currently consider
“wipes” or “towelettes” eligible
for inclusion in the OTC sunscreen monograph. See the 2011 ANPR on
dosage forms for FDA’s explanation.
Q. What is the process for a manufacturer of an ineligible dosage form that
does not fall within a TEA to receive marketing authorization? Testing requirements? Approval process? (Follow-up
question: What do we need to do to continue packaging SPF in a wipe form?)
A. The only recourse for these manufacturers is to submit a Time and Extent Application or a New Drug Application for
their product. The manufacturer could submit a citizen petition to amend the monograph, but citizen petitions require that the
amendment apply to drug conditions for
drug products eligible for inclusion in an
O TC monograph. Therefore, the manufacturer would have to demonstrate that its
product is eligible for inclusion in the OTC
Q. Is bar soap an eligible dosage form?
A. The only dosage forms that FDA currently considers eligible for inclusion in the
OTC sunscreen monograph are oils, lotions, creams, gels, butters, pastes, ointments, sticks and sprays. In order to be
eligible for inclusion in a monograph, all of
the drug product’s conditions of use, which
include its active ingredient, strength, route
of administration, specific OTC use or indication and dosage form, must have existed in the OTC drug marketplace on or
before May 11, 1972.
Q. How should makeup mineral powders with SPF be treated from a regulatory testing and labeling point of view?
A. Labeling with an SPF value implies that
the product is used for protection against
Q. If TiO2 is used as a pig-ment/opacifier, at low concentrations (~0.1%) and not claimed as
an OTC active, can it still be used
in an SPF formula with avobenzone?
A. In this drug product example, the
TiO2 must be considered to be an inactive ingredient in compliance with
21 CFR 330.1(e). That regulation requires that inactive ingredients must
not interfere with the effectiveness
of the drug product or with suitable
tests or assays to determine if the
product meets its professed standards of identity, strength, quality
and purity. The TiO2 must also not
be intended to furnish a drug effect
or activity, in compliance with the
active ingredient definition in 21
CFR 210.3(b) ( 7).
Dr. Tan’s answers to the questions
are most helpful. Unfortunately, they
address only a limited amount of the many
inquiries that have surfaced since their announcement of the Final Rule. There has
been a range of responses to the FDA’s Final
Ruling. Already, several sunscreen manufacturers have expressed displeasure over the
FDA’s proposed limitation of the SPF to 50+
that is in line with most other international
regulations. Johnson & Johnson, Energizer
Personal Care and others have submitted
public comments in opposition to this rule.
J&J said in its comments filed last month,
“By capping the SPF at 50, many consumers
will no longer have the choice to use higher
protection levels that they currently find
suitable for their individual needs. Higher
SPF sunscreens are safe, effective and are
an essential cornerstone of helping to keep
the public protected from the damaging effects of ultraviolet radiation.”2
Members of the Personal Care Product