Secondary Sunscreen Monograph Monograph

Accepted Names (English)

76

Avobenzone(common)Bemotrizinol(common)Benzophenone-3(common)Benzophenone-4(common)Benzophenone-8(common)Bisoctrizole(common)C.I. No. 77891(common)C.I. No. 77947(common)Cinoxate(common)DEA-methoxycinnamate(common)Diethanolamine methoxycinnamate(common)Dioxybenzone(common)Drometrizole trisiloxane(common)Ecamsule(common)Ensulizole(common)Enzacamene(common)Homomenthyl salicylate(common)Homosalate(common)Menthyl anthranilate(common)Meradimate(common)Octinoxate(common)Octisalate(common)Octocrilene(common)Octocrylene(common)Octyl methoxycinnamate(common)Oxybenzone(common)Padimate O(common)Sulisobenzone(common)Titanic anhydride(common)Titanium dioxide(common)Triethanolamine salicylate(common)Trolamine salicylate(common)Zinc oxide(common)(+-)-(3E,3'E)-(p-Phenylenedimethylidyne)bis[2-oxo-10-bornanesulfonic acid](proper)(2-Hydroxy-4-methoxyphenyl)(2-hydroxyphenyl)methanone(proper)(2-Hydroxy-4-methoxyphenyl)phenylmethanone(proper)(±)-3-(p-Methylbenzylidene)camphor(proper)1,7,7-Trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one(proper)1-(p-tert-Butylphenyl)-3-(p-methoxyphenyl)-1,3-propanedione(proper)1-[4-(1,1-Dimethylethyl)phenyl]-3-(4-methoxyphenyl)-1,3-propanedione(proper)2,2'-Dihydroxy-4-methoxybenzophenone(proper)2,2'-Methylenebis-(6-(2H-benzotriazol-2yl)-4-(1,1,3,3-tetramethylbutyl)-phenol)(proper)2,2'-[6-(4-Methoxyphenyl) -1,3,5-triazine-2,4-diyl]bis(5-[(2-ethylhexyl)oxy]phenol)(proper)2-(2H-Benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-{1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl}propyl)phenol(proper)2-Benzoyl-5-methoxy-1-phenol-4-sulfonic acid(proper)2-Cyano-3,3-diphenyl-2-propenoic acid, 2-ethylhexyl ester(proper)2-Ethoxyethyl p-methoxycinnamate(proper)2-Ethylhexyl p-(dimethylamino)benzoate(proper)2-Ethylhexyl p-methoxycinnamate(proper)2-Ethylhexyl salicylate(proper)2-Ethylhexyl-2-cyano-3,3-diphenylacrylate(proper)2-Hydroxy-4-methoxybenzophenone(proper)2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid(proper)2-Hydroxybenzoic acid 2-ethylhexyl ester(proper)2-Hydroxybenzoic acid 3,3,5-trimethylcyclohexyl ester(proper)2-Hydroxybenzoic acid, compd. with 2,2',2''-nitrilotris(ethanol) (1:1)(proper)2-Phenyl-1H-benzimidazole-5-sulphonic acid(proper)2-Phenylbenzimidazole-5-sulfonic acid(proper)3,3'-(1,4 Phenylenedimethylidene)bis(7,7-dimethyl-2-oxobicyclo[2.2.1]heptane-1- methanesulfonic acid)(proper)3,3,5-Trimethylcyclohexyl salicylate(proper)3-(4-Methoxyphenyl)-2-propenoic acid 2-ethoxyethyl ester(proper)3-(4-Methoxyphenyl)-2-propenoic acid, 2-ethylhexyl ester(proper)3-(4-Methoxyphenyl)-2-propenoic acid, compd. with 2,2'-iminobis(ethanol) (1:1)(proper)3-Benzoyl-4-hydroxy-6-methoxybenzenesulfonic acid(proper)4-(Dimethylamino)benzoic acid, 2-ethylhexyl ester(proper)4-tert-Butyl-4'-methoxydibenzoylmethane(proper)5-Benzoyl-4-hydroxy-2-methoxybenzenesulfonic acid(proper)5-Methyl-2-(1-methylethyl)cyclohexanol 2-aminobenzoate(proper)Anthranilic acid, p-menth-3-yl ester(proper)Salicylic acid 3,3,5-trimethylcyclohexyl ester(proper)Salicylic acid, compound with 2,2',2''-nitrilotriethanol (1:1)(proper)Terephthalylidene dicamphor sulfonic acid(proper)Terephthalylidene-3,3'-dicamphor-10,10'-disulfonic acid(proper)Titanium dioxide 5(proper)Zinc oxide 6(proper)p-Methoxycinnamic acid, compound with 2,2'-iminodiethanol (1:1)(proper)

Accepted Names (French)

76

Avobenzone(common)Bemotrizinol(common)Benzophenone-3(common)Benzophenone-4(common)Benzophenone-8(common)Bisoctrizole(common)C.I. No. 77891(common)C.I. No. 77947(common)Cinoxate(common)DEA-methoxycinnamate(common)Diethanolamine methoxycinnamate(common)Dioxybenzone(common)Drometrizole trisiloxane(common)Ecamsule(common)Ensulizole(common)Enzacamene(common)Homomenthyl salicylate(common)Homosalate(common)Menthyl anthranilate(common)Meradimate(common)Octinoxate(common)Octisalate(common)Octocrilene(common)Octocrylene(common)Octyl methoxycinnamate(common)Oxybenzone(common)Padimate O(common)Sulisobenzone(common)Titanic anhydride(common)Titanium dioxide(common)Triethanolamine salicylate(common)Trolamine salicylate(common)Zinc oxide(common)(+-)-(3E,3'E)-(p-Phenylenedimethylidyne)bis[2-oxo-10-bornanesulfonic acid](proper)(2-Hydroxy-4-methoxyphenyl)(2-hydroxyphenyl)methanone(proper)(2-Hydroxy-4-methoxyphenyl)phenylmethanone(proper)(±)-3-(p-Methylbenzylidene)camphor(proper)1,7,7-Trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one(proper)1-(p-tert-Butylphenyl)-3-(p-methoxyphenyl)-1,3-propanedione(proper)1-[4-(1,1-Dimethylethyl)phenyl]-3-(4-methoxyphenyl)-1,3-propanedione(proper)2,2'-Dihydroxy-4-methoxybenzophenone(proper)2,2'-Methylenebis-(6-(2H-benzotriazol-2yl)-4-(1,1,3,3-tetramethylbutyl)-phenol)(proper)2,2'-[6-(4-Methoxyphenyl) -1,3,5-triazine-2,4-diyl]bis(5-[(2-ethylhexyl)oxy]phenol)(proper)2-(2H-Benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-{1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl}propyl)phenol(proper)2-Benzoyl-5-methoxy-1-phenol-4-sulfonic acid(proper)2-Cyano-3,3-diphenyl-2-propenoic acid, 2-ethylhexyl ester(proper)2-Ethoxyethyl p-methoxycinnamate(proper)2-Ethylhexyl p-(dimethylamino)benzoate(proper)2-Ethylhexyl p-methoxycinnamate(proper)2-Ethylhexyl salicylate(proper)2-Ethylhexyl-2-cyano-3,3-diphenylacrylate(proper)2-Hydroxy-4-methoxybenzophenone(proper)2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid(proper)2-Hydroxybenzoic acid 2-ethylhexyl ester(proper)2-Hydroxybenzoic acid 3,3,5-trimethylcyclohexyl ester(proper)2-Hydroxybenzoic acid, compd. with 2,2',2''-nitrilotris(ethanol) (1:1)(proper)2-Phenyl-1H-benzimidazole-5-sulphonic acid(proper)2-Phenylbenzimidazole-5-sulfonic acid(proper)3,3'-(1,4 Phenylenedimethylidene)bis(7,7-dimethyl-2-oxobicyclo[2.2.1]heptane-1- methanesulfonic acid)(proper)3,3,5-Trimethylcyclohexyl salicylate(proper)3-(4-Methoxyphenyl)-2-propenoic acid 2-ethoxyethyl ester(proper)3-(4-Methoxyphenyl)-2-propenoic acid, 2-ethylhexyl ester(proper)3-(4-Methoxyphenyl)-2-propenoic acid, compd. with 2,2'-iminobis(ethanol) (1:1)(proper)3-Benzoyl-4-hydroxy-6-methoxybenzenesulfonic acid(proper)4-(Dimethylamino)benzoic acid, 2-ethylhexyl ester(proper)4-tert-Butyl-4'-methoxydibenzoylmethane(proper)5-Benzoyl-4-hydroxy-2-methoxybenzenesulfonic acid(proper)5-Methyl-2-(1-methylethyl)cyclohexanol 2-aminobenzoate(proper)Anthranilic acid, p-menth-3-yl ester(proper)Salicylic acid 3,3,5-trimethylcyclohexyl ester(proper)Salicylic acid, compound with 2,2',2''-nitrilotriethanol (1:1)(proper)Terephthalylidene dicamphor sulfonic acid(proper)Terephthalylidene-3,3'-dicamphor-10,10'-disulfonic acid(proper)Titanium dioxide 5(proper)Zinc oxide 6(proper)p-Methoxycinnamic acid, compound with 2,2'-iminodiethanol (1:1)(proper)

Approved Health Claims

9

Sun Protection Factor "X"/SPF "X" *
Broad spectrum
Absorbs throughout the UVA/UVB spectrum
UVA/UVB protection
Water/Sweat Resistant [40 minutes/80 minutes]
The PA rating system was developed in Japan and is currently used by most Asian countries
This system addresses UVA protection based on the Persistent Pigment Darkening method
For NPD ingredients, data must be provided to NNHPD through the labelling only submission pathway to support any additional information regarding the PA rating
For NHP products containing zinc oxide or a combination of zinc oxide and titanium dioxide, the PA rating is acceptable as additional information on the label, as long as it is truthful and not misleading. Valid data using a standardized and reproducible method must be available upon request. This does not apply to titanium dioxide alone which is less effective at blocking long-wave UVA (UVA I) rays

Approved Health Claims (Français)

9

Sun Protection Factor "X"/SPF "X" *
Broad spectrum
Absorbs throughout the UVA/UVB spectrum
UVA/UVB protection
Water/Sweat Resistant [40 minutes/80 minutes]
The PA rating system was developed in Japan and is currently used by most Asian countries
This system addresses UVA protection based on the Persistent Pigment Darkening method
For NPD ingredients, data must be provided to NNHPD through the labelling only submission pathway to support any additional information regarding the PA rating
For NHP products containing zinc oxide or a combination of zinc oxide and titanium dioxide, the PA rating is acceptable as additional information on the label, as long as it is truthful and not misleading. Valid data using a standardized and reproducible method must be available upon request. This does not apply to titanium dioxide alone which is less effective at blocking long-wave UVA (UVA I) rays

Cautions & Contraindications

5

cautionFor external use only

cautionWhen using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water (US FDA 2021).

cautionStop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if rash occurs****

cautionKeep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

contraindicationDo not use on broken skin (US FDA 2021)

Ingredients Covered

2

2,2'-Methylenebis-(6-(2H-benzotriazol-2yl)-4-(1,1,3,3-tetramethylbutyl)-phenol)2,2'-[6-(4-Methoxyphenyl) -1,3,5-triazine-2,4-diyl]bis(5-[(2-ethylhexyl)oxy]phenol)

Secondary Sunscreen Monograph