FDA Allowable Ingredients in Sunscreens

January 19, 2010 by admin · Leave a Comment 

The following are the FDA allowable active ingredients in sunscreens:

UV-filter

Other names

Maximum concentration

Permitted in these countries

Results of safety testing

p-Aminobenzoic acid PABA 15% (5% EC-will be banned from sale to consumers from 8 October 2009) EC, USA, AUS Protects against skin tumors in mice. Shown to increase DNA defects, however, and is now less commonly used.
Padimate O OD-PABA, octyldimethyl-PABA, σ-PABA 8% (EC,USA,AUS) 10% (JP)

(Not currently supported in EU and may be delisted)

EC, USA, AUS, JP Not tested
Phenylbenzimidazole sulfonic acid Ensulizole, Eusolex 232, PBSA, Parsol HS 4% (US,AUS) 8% (EC) 3% (JP) EC,USA, AUS, JP Genotoxic in bacteria
Cinoxate 2-Ethoxyethyl p-methoxycinnamate 3% (US) 6% (AUS) USA, AUS Not tested
Dioxybenzone Benzophenone-8 3% USA, AUS Not tested
Oxybenzone Benzophenone-3, Eusolex 4360, Escalol 567 6% (US) 10% (AUS,EU) 5% (JP) EC, USA, AUS, JP Not tested
Homosalate Homomethyl salicylate, HMS 10% (EC, JP) 15% (US,AUS) EC, USA, AUS, JP Not tested
Menthyl anthranilate Meradimate 5% USA, AUS Not tested
Octocrylene Eusolex OCR, 2-cyano-3,3diphenyl acrylic acid, 2-ethylhexylester 10% EC,USA, AUS, JP Increases ROS
Octyl methoxycinnamate Octinoxate, EMC, OMC, Ethylmethoxycinnamate, Escalol 557, 2-ethylhexyl-paramethoxycinnamate, Parsol MCX 7.5% (US) 10% (EC,AUS)20% (JP) EC,USA, AUS, JP
Octyl salicylate Octisalate, 2-Ethylhexyl salicylate, Escalol 587, 5% (EC,USA,AUS) 10% (JP) EC,USA, AUS, JP Not tested
Sulisobenzone 2-Hydroxy-4-Methoxybenzophenone-5-sulfonic acid,

3-benzoyl-4-hydroxy-6-methoxybenzenesulfonic acid, Benzophenone-4, Escalol 577

5% (EC) 10% (US, AUS, JP) EC,USA, AUS, JP
Trolamine salicylate Triethanolamine salicylate 12% USA, AUS Not tested
Avobenzone 1-(4-methoxyphenyl)-3-(4-tert-butylphenyl)propane-1,3-dione, Butyl methoxy dibenzoylmethane, BMDBM, Parsol 1789, Eusolex 9020 3% (US) 5% (EC,AUS)10% (JP) EC, USA, AUS, JP Not available
Ecamsule Mexoryl SX, Terephthalylidene Dicamphor Sulfonic Acid 10% EC,AUS (US:Approved in certain formulations up to 3% via New Drug Application (NDA) Route) Protects against skin tumors in mice
Titanium dioxide CI77891 25% (No limit Japan) EC,USA, AUS, JP Not tested
Zinc oxide 25% (US) 20% (AUS)

(EC-25% provided particle size >100 nm) (Japan, No Limit)

EC,USA, AUS, JP Protects against skin tumors in mice

Active Ingredients for Sunscreens and Sunblocks

January 19, 2010 by admin · Leave a Comment 

The principal ingredients in sunscreens are usually aromatic molecules conjugated with carbonyl groups. This general structure allows the molecule to absorb high-energy ultraviolet rays and release the energy as lower-energy rays, thereby preventing the skin-damaging ultraviolet rays from reaching the skin.

So, upon exposure to UV light, most of the ingredients (with the notable exception of avobenzone) do not undergo significant chemical change, allowing these ingredients to retain the UV-absorbing potency without significant photodegradation. A chemical stabilizer is included in some sunscreens containing avobenzone to slow its breakdown – examples include formulations containing Helioplex and AvoTriplex. The stability of avobenzone can also be improved by bemotrizinol, octocrylene and various other photostabilisers.

Some sunscreens also include enzymes like photolyase, which are claimed to be able to repair UV-damaged DNA.

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