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.







