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New Sunscreen Rules Proposed by the Food & Drug Administration

by kelly / October, 13 2021 01:30

Photo of a woman hands applying sunscreen in the shape of a sun to a man's back

If you have a high SPF chemical sunscreen in your cabinet you might need to replace it soon. The US Food and Drug Administration (FDA) is proposing new requirements that may affect if your chemical sunscreen is considered safe (all-mineral sunscreens like ours are considered safe), what the max SPF level is, and if it truly protects you against all UV rays like ours do. So what are these new updates and how do you buy the right sunscreen – well we’ve got you covered.

FDA Regulates Sunscreens

As a refresher, sunscreens are actually considered over-the-counter (OTC) drugs. Anything with an active ingredient is considered an OTC. For example, your toothpaste with fluoride is an OTC.

OTC’s are regulated by the US government through the FDA. The FDA creates and proposes rules around all OTC drugs. Today OTCs must follow an OTC monograph – it’s like a rule book that establishes such things as uses, doses, labeling, testing, and what can be marketed.

I think it’s good that sunscreens are regulated. You see, most cosmetic products are not. So I feel like the FDA’s sunscreen regulations give you a bit more security over what you’re putting on your skin.

FDA Proposed Changes to Sunscreens

Recently the FDA proposed new changes to sunscreens in order to bring them up to date with current science. It will, according to the FDA, ensure “that sunscreens are safe and effective for frequent, life-long use and provide consumers with the protection they expect from these products.” That sounds like a good reason to me!

So what are the main changes that might affect you:

  1. Maximum SPF – proposes that the maximum labeled SPF value should be SPF 60+. While the proposed maximum labeled SPF value is 60+, the proposed order permits the marketing of sunscreen products formulated with SPF values up to 80. I’ll be honest, this is a little confusing to me – it sounds like the bottle wouldn’t be able to say more than SPF 60+ but other marketing materials might be able to say up to SPF 80? I’ll have to watch how this plays out.
  2. Active Ingredients – proposes GRASE (generally recognized as safe) status for sunscreens containing zinc oxide and titanium dioxide (yes, like our sunscreens!); not GRASE status for sunscreens containing aminobenzoic acid and trolamine salicylate because of data showing safety issues; and not GRASE status for sunscreens containing cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone because of inadequate data to support a safety finding.
  3. Broad Spectrum – proposes a requirement that all sunscreens with SPF values of 15 and above satisfy broad spectrum requirements (our SPF products do).

To see the full list of changes check out the FDA website here.

Suncare Smarts

No need yet to review your bathroom cabinet. These proposals don’t take effect until they are finalized and some of the non-GRASE ingredients might become GRASE as more data is collected. Also, there is a 45-day public comment period which began when the FDA issued the proposed order. The FDA will issue a final order that will have an effective date after reviewing and considering the comments.

But it’s a good time to start thinking about what type of sunscreen you may want to buy in the future. As a reminder our sunscreens are zinc only and offer SPF 30 broad spectrum protection so they meet the FDA’s proposed new rules.

We’ll keep our Suncare Smarts series up to date on any final changes by the FDA.

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