Australian regulatory guidelines for sunscreens (ARGS)

Version 1.1

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22 January 2016

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).

Table 3. Permitted active ingredients for therapeutic sunscreens.
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

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