Bottom Line: New US Regulations now prohibit
certain claims on sunscreen labels, including "sunblock",
"waterproof", "sweat proof", references to
immediate protection, over two hours' protection (unless FDA
approved) and SPF claims of over 50 (without evidence). Health
Canada is taking note.
We have watched with interest the new regulations implemented by
the US Food and Drug Administration ("FDA") on sunscreen
labels . Notably, now:
Effectiveness Test - Sunscreens must pass a
standard test showing their effectiveness against both UVA and UVB
rays before they can be labelled "Broad Spectrum" and
"SPF 15" or higher;
More Specific Water Resistance Claims -
Sunscreens that claim water resistance must tell consumers how long
the protection will last while swimming or sweating, based on
standard testing. The permitted times are either 40 or 80 minutes.
"waterproof" and "sweat proof" claims are now
No More "Sunblock"; Claimed Duration
- Products may not be labelled as "sunblocks"
and cannot claim to offer immediate protection upon application.
Furthermore, claims that a sunscreen offers more than two hours of
sun protection are prohibited, unless backed by data and approved
by the FDA; and
Max 50 SPF - Lastly, a proposal was made by
the FDA which would prevent sunscreens from being labelled with an
SPF greater than 50 without evidence being provided of its higher
Initially, the compliance date was to be June 18, 2012. However,
due to difficulties companies faced in making these changes before
the deadline, the FDA extended the date to December 17, 2012.
With these changes happening south of the border, Health
Canada has acknowledged the need to update sunscreen labelling
regulations in Canada. It has said it will review
sunscreen rules in light of the FDA's changes and will also
move towards adopting an internationally accepted test for UVA and
UVB protection. However, Health Canada has not set any
timelines for revising sunscreen regulations in Canada to
New US Regulations now prohibit certain claims on sunscreen
labels, including "sunblock", "waterproof",
"sweat proof", references to immediate protection, over
two hours' protection (unless FDA approved) and SPF claims of
over 50 (without evidence).
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