FDA Approved Sunscreen Ingredients

USA Federal Drugs Administration (FDA) has approved the following 17 active sunscreen ingredients for use in over-the-counter sunscreen products:

  1. Aminobenzoic acid (PABA) in concentration up to 15 percent (in grams of the total mass of the sunscreen product).
  2. Avobenzone up to 3 percent.
  3. Cinoxate up to 3 percent.
  4. Dioxybenzone up to 3 percent.
  5. 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.
  6. Homosalate up to 15 percent.
  7. Menthyl anthranilate up to 5 percent.
  8. Octocrylene up to 10 percent.
  9. Octyl methoxycinnamate up to 7.5 percent.
  10. Octyl salicylate up to 5 percent.
  11. Oxybenzone up to 6 percent.
  12. Padimate O up to 8 percent.
  13. Phenylbenzimidazole sulfonic acid up to 4 percent.
  14. Sulisobenzone up to 10 percent.
  15. Titanium dioxide up to 25 percent.
  16. Trolamine salicylate up to 12 percent.
  17. 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 drugs, so they may contain only FDA approved active ingredients listed above.

Beside active ingredients, there are several other sunscreens ingredients, including water, salt, herbal extracts, oils or alcohols that hold the active ingredients, preservatives, fragrances, etc, 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)

Safe Sunscreen?

If you want to be safe from the sun, avoid the sun. Next step is wearing sun-protecting clothes, together with applying sunscreen.

There is no sunscreen that is 100% safe. Also, people often don’t apply sunscreen generously enough, or often enough (re-applying every 2 hours is recommended).

Safe sunscreen product should:

  • have sun protective factor (SPF) at least 15
  • should not contain any harmful ingredients

Warnings:

  • Terms like organic or natural sunscreen may be highly misleading. Everyone can put some herbs in the sunscreen and claim it’s organic. Even certified organic sunscreens are not safe just from being organic – allergies often develop against organic compounds.
  • Sunscreens used today are also never “all day”or completely “waterproof”, as some producers claim.

Sunscreen Rating

Sunscreen ratings by independent reviewer can help you in choosing appropriate sunscreen.

Further Reading:

Harmful Sunscreen Ingredients
Natural and Organic Sunscreen
Skin Cancer Causes and Risk Factors
Types of Skin Cancer

References:

  1. Sunscreen ingredients approved in EU, AU, or Japan (cosmeticsdatabase.com)

Further Reading :
  • Harmful Sunscreen Ingredients & Sunscreen Ratings
  • What Is a Good Sunscreen – Sunscreens Products, Sunscreen Facts
  • Natural and Organic Sunscreen