FDA sunscreen guidelines
June 17, 2011
SIGNIFICANT changes to
sunscreen labelling are set to
sweep across the USA next year, as
part of new regulations put in place
by the Food and Drug Administration.
The new rules are designed to
help consumers decide on how to
buy and use sunscreen by clarifying
the effectiveness of individual
products, and to ensure proper
labelling and manufacture, and
safety benchmarks are met.
Changes to the current sunscreen
legislation will see the a shift from
labelling standards which only
focused on UVB radiation, to the
establishment of a broad spectrum
test proceedure which measures
both UVA and UVB rays.
As such, only sunscreens which
pass the FDA’s broad spectrum test
will be able to carry ‘Broad
Spectrum’ SPF labelling.
Broad spectrum sunscreens with
an SPF value of 15 or higher will
also be able to claim to reduce the
risk of skin cancer and early skin
aging if used as directed with other
sun protection measures, whilst
non-Broad Spectrum sunscreens
and Broad Spectrum sunscreens
with an SPF value between 2 and
14 can only claim to help prevent
sunburn.
In addition manufacturers will no
longer be able to make
“sweatproof” or “sunblock” claims
on their product labelling, because,
according to the FDA, these claims
overstate their effectiveness.
Labelling must also not claim to
offer over two hours worth of
protection, or to provide immediate
protection unless the FDA has
approved these claims based on
product data.
Products also cannot claim to be
“waterproof”, and any water
resistance claims on the front of
labels must indicate whether the
sunscreen remains effective for 40
minutes or 80 minutes while
swimming or sweating, based on
standardised testing.
Sunscreens that are not water
resistant must include a direction
instructing consumers to use a
water resistant sunscreen if
swimming or sweating.
The new rules will take effect by
May next year, however the FDA
has said “consumers may begin to
see changes to sunscreen labels
before the effective date”.
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