FDA has previously (as of September 29, 2021) recognized 16 sunscreen ingredients as GRASE (generally regarded as safe and effective).
The FDA issued a proposed order on 24Sept2021 (yeah, this is how I write dates 😊), to remove the GRASE status from 14 sunscreen ingredients.
🤯 🤯 🤯
So, does that mean only 2 sunscreen ingredients are safe (and effective)?
Yeah, pretty much exactly. Here’s what the new (proposed) classification looks like:
|Generally Recognized As Safe and Effective (GRASE)||Additional data required||No longer GRASE status|
|Titanium dioxide||Cinoxate (aka 2-ethoxyethyl p-methoxycinnamate)||PABA (para-aminobenzoic acid, p-aminobenzoic acid, vitamin B10, vitamin Bx, bacterial vitamin H1)|
|Zinc oxide||Dioxybenzone (aka benzophenone-8)||Trolamine salicylate1|
|Ensulizole (aka phenylbenzimidazole sulfonic acid)|
|Meradimate (aka menthyl-o-aminobenzoate, anthranilic acid menthyl ester, anthranilic acid p-menth-3-yl ester)|
|Octinoxate (aka octyl methoxycinnamate, uvinul MC80, (E)-3-(4-methoxyphenyl) prop-2-enoic acid 2-ethylhexyl ester)|
|Octisolate (aka octyl salicylate, 2-ethylhexyl salicylate)|
|Octocrylene (uvinul N-539)|
|Padimate O (2-ethylhexyl dimethyl PABA, escalol 507)|
|Sulisobenzone (benzophenone-4, and sodium sulisobenzone is aka benzophenone-5)|
|Oxybenzone (benzophenone-3, 2-hydroxy-4-methoxybenzophenone)|
|Avobenzone (4-tert-butyl-4’-methoxydibenzoylmethane, butylmethoxydibenzoylmethane)|
1FDA removed GRASE status from trolamine salicylate in 2019. Trolamine salicylate is used in a variety of over-the-counter topical pain relievers.
Why is FDA removing the GRASE status from PABA and trolamine salicylate?
Trolamine salicylate includes some pretty serious side effects like bleeding, vomiting, hyperventilation, coma, and death (check out Reference 1). It might also be a pain killer in some OTC topical pain relief creams (at least, I think it is, one site indicated FDA classified trolamine salicylate as unproven for use as an external pain reliever back in 1983, however, the FDA was asked to re-evaluate in 1994, and most sites indicate it may be sold as a pain reliever).
PABA presents risks of possible allergic dermatitis, photosensitivity, and some peer reviewed research links PABA with endocrine disruption, specifically thyroid hormone disrupting. PABA has been banned (or, if you prefer, outlawed) as a sunscreen ingredient from Europe and Canada (I thought this happened much earlier than it did, it seems PABA was only recently banned for use in these countries sometime around 2018).
What additional data does FDA require for those 12 sunscreen ingredients?
Did you know the FDA conducts its own studies sometimes? When solid peer reviewed scientific data is lacking, FDA will sometimes conduct its own study to determine the safety and efficacy of an ingredient. This happened a few years ago with the sunscreen ingredient, avobenzone. FDA enrolled 24 people in a study to see whether avobenzone soaks through skin and is absorbed into the bloodstream. 4 types of sunscreen products (example creams, lotions, gels, sprays) were used in the study, and the results were published in the Journal of American Medical Association (JAMA) back in 2019. These results showed that regardless of the type of product, avobenzone was found in the bloodstream of these participants.
The same type of absorption rates have been documented in literature for these other sunscreens in that middle column above. For this reason, FDA is requesting that companies perform additional safety and efficacy studies before selling sunscreens containing these ingredients.
Why should you worry that these ingredients absorb into your skin?
Well, aside from the fact that sunscreens only work as sunscreens when they sit on your skin (rather than absorb into it), here’s why this matters:
- Chemical sunscreens (every ingredient listed in the table above is a chemical sunscreen except the 2 remaining GRASE ingredients: zinc oxide and titanium dioxide), form free radicals and heat when they’re hit by UV light. No problem when this happens on the surface of your skin (since those skin cells are dead anyways), big problem when it happens in your living skin layers.
- A number of these ingredients are known endocrine disruptors, specifically disrupting thyroid hormones and/or sex hormones (either acting as xenoestrogens, interrupting testosterone production, or otherwise messing with your body’s natural communication pathways).
There are a number of other reasons also, (like oxybenzone… strike that, the entire class of benzophenones were awarded the Contact Allergen of the Year by the American Contact Dermatitis Association in 2014).
And, then there are the bigger than your health concerns, like the health of the planet. Some of these sunscreen ingredients cause coral bleaching, killing the algae responsible for photosynthesis in the coral, thus killing the coral itself. Octinoxate at levels of 1 part per billion in seawater caused complete bleaching in coral living in the sea water for just 14 days. In the summer of 2015, water samples gathered within 30 yards of the coastline along Maui were found to contain levels of octinoxate at up to 967 part per trillion, just 33 parts per trillion below the 1 part per billion (ppb) level that completely bleached coral in 14 days (Reference 2).
How can you protect your skin from sun damage?
You may be wondering what are your options.
Here’s what they are:
- Clothing: any kind of clothing provides sun protection even if it doesn’t have a UPF rating
- Physical (non-nano/non-micronized) sunscreens aka mineral sunscreens aka titanium dioxide and zinc oxide
- Antioxidants (both topically applied and in your diet)
Want to find out how antioxidants and sunscreens are different? Check out this podcast episode where we discuss the differences between physical and chemical sunscreens and antioxidants.
About the author
Brandy Searcy’s a pharmaceutical formulation scientist and self-proclaimed health geek who loves hiking, gardening, bird-watching, and body boarding.
Her struggle with acne during her teens and 20s led to a holistic and healthy approach to skincare, embracing skin as an organ to be loved and cared for rather than a canvas to wage war on.
Since 2008, she’s been developing all-in-one products for a simple routine at home, & she started Rain Organica with a mission to take the overwhelm out of skincare.
Try Rain Organica for yourself with The Essentials Kit, a complete skincare routine in just 3 steps.
https://haereticus-lab.org/octinoxate/ scroll to middle of article for water samples collected off Hawaii and photos of coral bleaching
Matta MK, Zusterzeel R, Pilli NR, et al. Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial. JAMA. 2019;321(21):2082–2091. doi:10.1001/jama.2019.5586 https://jamanetwork.com/journals/jama/fullarticle/2733085
Banks D, Dermatology News, March 14, 2014, Benzophenones named 2014 Contact Allergen of the Year, https://www.mdedge.com/dermatology/article/80980/psoriasis/benzophenones-named-2014-contact-allergen-year