Australian regulatory guidelines for sunscreens (ARGS)
Version 1.1
9. Permitted ingredients
9.1 Sunscreening agents permitted as active ingredients
The only sunscreening active ingredients permitted in therapeutic sunscreens are those included in Table 3, and must be within the maximum concentrations (weight/weight) stated in the list. Some of these sunscreening active ingredients have certain additional restrictions regarding the type of dosage forms they can be used in. Sponsors should consult the Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015 for what restrictions apply to each ingredient.
The labelling must include the Australian Approved Name (AAN) for each active sunscreening ingredient.
Table 3 includes synonyms, abbreviations, trade names, International Non-proprietary Names (INN), International Nomenclature Cosmetic Ingredient (INCI) names and Chemical Abstract Services (CAS) numbers for information.
Sponsors wanting to market a therapeutic sunscreen product containing a sunscreening active ingredient which is not on the list of permitted substances in therapeutic sunscreens must submit data to establish the safety and efficacy of the ingredient under its proposed conditions of use (see section 10).
| Australian Approved Name (AAN) | Synonyms, Abbreviations, Trade Names, CAS Number |
Maximum Concentration (w/w) |
|---|---|---|
|
Bemotrizinol [= INN] |
Bis-ethylhexyloxyphenol methoxyphenol triazine [= INCI name] Bemotrizinolum Escalol S Tinosorb S CAS No: 187393-00-6 |
10% |
|
Benzylidene camphor sulfonic acid [= INCI name] |
alpha-(2-Oxoborn-3-ylidene)toluene-4-sulphonic acid Meroxyl SL CAS No: 56039-58-8 |
6% |
|
Butyl methoxy dibenzoylmethane [= INCI name] |
BMDM 4-tert-butyl-4'-methoxy dibenzoylmethane 1-(4 tert butylphenyl)-3(4-methoxyphenyl)-propane-1,3-dione Avobenzone [= INN] CAS No: 70356-09-1 |
5% |
|
Camphor benzalkonium methosulfate [= INCI name] |
N,N,N-Trimethyl-4-(oxoborn-3-ylidenemethyl)anilinium methyl sulfate Meroxyl SO CAS No: 52793-97-2 |
6% |
|
Cinoxate [= INN and INCI name] |
2-Ethoxyethyl para-methoxycinnamate CAS No: 104-28-9 |
6% |
|
Diethylamino hydroxybenzoyl hexyl benzoate [= INCI name] |
Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-hexyl ester Uvinul A Plus CAS No: 302776-68-7 |
10% |
|
Dioxybenzone [= INN] |
Benzophenone 8 [= INCI name] CAS No: 131-53-3 |
3% |
|
Disodium phenyl dibenzimidazole tetrasulfonate [= INN and INCI name] |
1H-Benzimidazole-4,6-disulfonic acid, 2,2'-(1,4-phenylene)bis-, disodium salt Bisimidazylate Neo Heliopan AP CAS No: 180898-37-7 |
10% |
|
Drometrizole trisiloxane [= INCI name] |
2-(2H-Benzotriazol-2-yl)-4-methyl-6[2-methyl-3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-disiloxanyl]-propyl- phenol Silatrizole Mexoryl XL CAS No: 155633-54-8 |
15% |
|
Ecamsule [= INN and INCI name] |
Terephthalylidene dicamphor sulfonic acid Mexoryl SX CAS No: 90457-82-2; 92761-26-7 |
10% |
|
Homosalate [= INN and INCI name] |
Homomenthyl salicylate 3,3,5-Trimethylcyclohexyl 2-hydroxybenzoate CAS No: 118-56-9 |
15% |
| Isoamyl methoxy-cinnamate |
Isoamyl p-methoxycinnamate [= INCI name] Isoamyl-4-methoxycinnamate Isopentenyl-4-methoxycinnamate Amiloxate [= INN] CAS No: 71617-10-2 |
10% |
|
4-Methylbenzylidene camphor [= INCI name] |
3-(4-Methylbenzylidene)-dl-camphor Enzacamene [= INN] CAS No: 36861-47-9; 38102-62-4 |
4% |
|
Menthyl anthranilate [= INCI name] |
Menthyl 2-aminobenzoate 5-Methyl-2-(1-methylethyl) cyclohexanol-2-aminobenzoate Meradimate [= INN] CAS No: 134-09-8 |
5% |
|
Methylene bis-benzo-triazolyl-tetramethyl-butylphenol [= INCI name] |
2,2'-Methylene-bis-6-(2H-benzotriazol-2yl)-4-(tetramethyl-butyl)-1,1,3,3-phenol Bisoctrizole [= INN] Tinosorb M CAS No: 103597-45-1 |
10% |
|
Octocrylene [= INCI name] |
Octocrilene [= INN] 2-cyano-3,3-diphenyl acrylic acid, 2-ethyl hexyl ester 2-Ethylhexyl-2-cyano-3,3 diphenylacrylate Uvinul N CAS No: 6197-30-4 |
10% |
| Octyl methoxy-cinnamate |
Ethylhexyl methoxycinnamate [= INCI name] Octinoxate [= INN] Uvinul MC CAS No: 5466-77-3 |
10% |
| Octyl salicylate |
Ethylhexyl salicylate [= INCI name] 2-Ethylhexyl salicylate Octisalate [= INN] CAS No: 118-60-5 |
5% |
| Octyl triazone |
Ethylhexyl triazone [= INCI name] 2,4,6-Trianalino-(p-Carbo-2'-ethylhexyl-1'oxy)-1,3,5-triazine Uvinul T CAS No: 88122-99-0 |
5% |
|
Oxybenzone [= INN] |
Benzophenone 3 [= INCI name] 2-Benzoyl-5-methoxyphenol Uvinul M CAS No: 131-57-7 |
10% |
|
Padimate O [= INN] |
Ethylhexyl dimethyl PABA [= INCI name] 2-Ethylhexyl 4-dimethylaminobenzoate Octyl dimethyl PABA CAS No: 21245-02-3; 58817-05-3 |
8% |
|
PEG-25 PABA [= INCI name] |
Ethoxylated ethyl 4-aminobenzoate PEG25 PABA Uvinul P CAS No: 113010-52-9; 116242-27-4 |
10% |
|
Phenylbenzimidazole sulfonic acid [= INCI name] |
2-Phenylbenzimidazole-5-sulfonic acid 2-Phenyl-5-sulfobenzimidazole Ensulizole [= INN] CAS No: 27503-81-7 |
4% |
|
Polysilicone-15 [= INCI name] |
Dimethicodiethylbenzalmalonate Diethylbezylidene malonate dimethicone Diethylmalonylbenzylidene oxypropene dimethicone Parsol SLX CAS No: 207574-74-1 |
10% |
|
Sulisobenzone [= INN] |
Benzophenone 4 [= INCI name] 5-Benzoyl-4-hydroxy-2-methoxybenzene sulphonic acid Uvinul MS CAS No: 4065-45-6 |
10% |
|
Sulisobenzone sodium [= INN] |
Benzophenone 5 [= INCI name] 5-Benzoyl-4-hydroxy-2-methoxybenzene sulphonic acid, sodium salt CAS No: 6628-37-1 |
10% |
|
Titanium dioxide [= INN and INCI name] |
E171 CAS No: 13463-67-7 |
25% |
| Triethanolamine salicylate |
TEA-salicylate [= INCI name] Trolamine salicylate [= INN] CAS No: 2174-16-5 |
12% |
|
Tris-biphenyl triazine [= INCI name] |
1,3,5-Triazine, 2,4,6-tris([1,1'-biphenyl]-4-yl)- Tinosorb A2B CAS No: 31274-51-8 |
10% |
|
Zinc oxide [= INN and INCI name] |
Pigment white 4 CAS No: 1314-13-2 |
No limit |
9.2 Excipients
Only those excipients approved by the TGA for use in topical medicines may be used in therapeutic sunscreens. In some cases the TGA has set limits on the amounts of such ingredients and sunscreens must comply with those limits. For more information on the substances that may be used in Listed medicines supplied in Australia and the restrictions applying to their use, please consult the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2015