Why Sunscreen Is a Drug in Some Markets and a Cosmetic in Others
How the US, EU, and Australia treat SPF products differently, and where sunscreen claims can knock your notification out of the cosmetic lane.
How the US, EU, and Australia treat SPF products differently, and where sunscreen claims can knock your notification out of the cosmetic lane.
Any SPF claim in Canada pulls the product into the drug pathway, meaning a DIN or NPN, not a Cosmetic Notification Form.
Titanium dioxide is treated very differently as a sunscreen active than as a colorant. Here is why the distinction changes your entire filing.
How zinc oxide behaves differently in a cosmetic moisturizer versus a regulated sunscreen, and why the percentage alone doesn't decide.
How benzophenone-type UV filters are treated on Canada's Hotlist and why adding one can turn your cosmetic into a sunscreen drug.
Any sun protection factor claim shifts a product out of cosmetic territory and into drug or natural health product rules, with different labeling entirely.
Sunscreen is regulated as an OTC drug in the US, not a cosmetic, which changes which rules actually apply to an SPF product.
Titanium dioxide is the same white powder in a foundation and a sunblock, but the claim on your label decides which rulebook governs it.
One sun-protection claim moves a simple lip balm out of cosmetic notification and into drug regulation entirely, with a different process altogether.
Zinc oxide (CAS 1314-13-2) works fine as a cosmetic pigment, until your claim language turns it into an OTC drug ingredient.
Sunscreen in Australia is usually a therapeutic good, not a cosmetic, yet AICIS still governs the ingredients behind it. Here is how the two regimes connect.
Why a soothing after-sun gel files as a cosmetic while any product claiming to prevent or block sunburn is regulated as a drug instead.