FDA Approved Sunscreen Ingredients
US Federal Drugs Administration (FDA) has approved the following 17 active sunscreen ingredients for use in over-the-counter sunscreen products:
- Aminobenzoic acid (PABA) in concentration up to 15 percent (in grams of the total mass of a sunscreen product)
- Avobenzone up to 3 percent
- Cinoxate up to 3 percent
- Dioxybenzone up to 3 percent
- Ecamsule (terephthalylidene dicamphor sulfonic acid) up to 10 percent, approved by FDA on July 24, 2006, is commercially available as Anthelios SX in US, and Mexoryl SX in EU and AU
- Homosalate up to 15 percent
- Menthyl anthranilate up to 5 percent
- Octocrylene up to 10 percent
- Octyl methoxycinnamate up to 7.5 percent
- Octyl salicylate up to 5 percent
- Oxybenzone up to 6 percent
- Padimate O up to 8 percent
- Phenylbenzimidazole sulfonic acid up to 4 percent
- Sulisobenzone up to 10 percent
- Titanium dioxide up to 25 percent
- Trolamine salicylate up to 12 percent
- Zinc oxide up to 25 percent.
Note that only active sunscreen ingredients that protect skin against UV-rays are listed. Sunscreens sold in USA pharmacies are considered as over-the-counter (OTC) drugs, so they may contain only FDA approved active ingredients listed above.
Beside active ingredients, there are several other sunscreens ingredients in sunscreens, including water, salt, herbal extracts, oils or alcohols that hold the active ingredients, preservatives, fragrances, and so on, that are considered as cosmetic ingredients, and are therefore not a subject of FDA approval authority.
Sunscreen Ingredients, Approved in EU, AU or Japan
The following sunscreen ingredients are not approved by FDA, but are approved in EU, AU (by therapeutic goods administration (TGA)) or Japan (1):
- 1-(3,4-dimetoxyphenyl)-4,4-dimethyl-1,3-penta nediene (EU)
- 3-methylbenzylidene camphor (AU)
- 4-(2-beta-glucopyranosiloxy) propoxy-2-hydroxybenzophenone (EU)
- 4-methylbenzylidene camphor (AU, Japan)
- Benzocaine (EU)
- Benzophenone-1 and -2,-5,-6,-9 (EU)
- Benzylidene camphor sulfonic acid (AU, Japan)
- Camphor benzalkonium methosulphate (AU, Japan)
- Diethylamino hydroxybenzoylhexyl benzoate (AU)
- Diethylexyl butamido triazone (AU)
- Diisopropyl methyl cinnamate (EU)
- Disodium phenyl dibenzimidazole tertrasulfonate (AU, Japan)
- Ethylexyl dimethoxybenzylidene dioxoimidazolidene propionate (EU)
- Ethylexyl triazone (EU, AU, Japan)
- Ferulic acid (EU)
- Glycerylethylexylhexanoate dimethoxicinnamate (EU)
- Glyceryl PABA (EU)
- Isoamyl p-methoxicinnamate (AU, Japan)
- Isopentyl trimethoxicinnamate trisiloxane (EU)
- Isopropyl methoxicinnamate (EU)
- Methylene bis-benzotriazolyl tetramethylbutylphenol (AU, Japan)
- PEG-25 PABA (AU, Japan)
- Pentyl dimethyl PABA (EU)
- Polyacrylamidomethylbenzylidene camphor (AU)
- Polysilicone-15 (AU)
- Tinosarb S (AU)
What Is a Safe Sunscreen?
If you want to be safe from the sun, avoid the sun. The next step is wearing sun-protecting clothes, together with applying sunscreen.
There is no sunscreen that is 100% safe. Also, people often do not apply sunscreen generously or often enough (re-applying every 2 hours is recommended).
Safe sunscreen product should:
- Have sun protective factor (SPF) at least 15
- Not contain any harmful ingredients
- Terms, like organic or natural sunscreen may be highly misleading. Any producer can put some herbs in the sunscreen and claim it is organic. Even certified organic sunscreens are not safe just from being organic – allergies to organic compounds are possible.
- Sunscreens used today are also never “all day”or completely “waterproof”, as some producers claim.
Sunscreen ratings by independent reviewer can help you in choosing appropriate sunscreen.
- Harmful Sunscreen Ingredients
- Natural and Organic Sunscreen
- Skin Cancer Causes and Risk Factors
- Types of Skin Cancer
- Sunscreen ingredients approved in EU, AU, or Japan (cosmeticsdatabase.com)
Article reviewed by Dr. Greg. Last updated on January 1, 2013