FDA Allowable Ingredients in Sunscreens
January 19, 2010 by admin
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 |
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