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 prohibited;
- 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 value.
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.
CANADA'S PLANS?
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 date.
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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