Primary Sunscreen Monograph

Monograph
704products
product · Topical

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

15
  • Sun Protection Factor "X"/SPF "X"*
  • Helps prevent sunburn
  • Sunscreen
  • Sunburn protectant
  • Helps protect from sunburn
  • Broad spectrum
  • Filters/Screens UVA/UVB rays
  • Absorbs throughout the UVA/UVB spectrum to provide sunburn protection
  • UVA/UVB protection
  • Water/Sweat Resistant [40 minutes/80 minutes]
  • If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun
  • 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)

15
  • Sun Protection Factor "X"/SPF "X"*
  • Helps prevent sunburn
  • Sunscreen
  • Sunburn protectant
  • Helps protect from sunburn
  • Broad spectrum
  • Filters/Screens UVA/UVB rays
  • Absorbs throughout the UVA/UVB spectrum to provide sunburn protection
  • UVA/UVB protection
  • Water/Sweat Resistant [40 minutes/80 minutes]
  • If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun
  • 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

6
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**** (US FDA 2021).
cautionKeep out of reach of children. If swallowed, call a poison control centre or get medical help right away
cautionOther warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging (US FDA 2021).
contraindicationDo not use on broken skin (US FDA 2021).

Ingredients Covered

74
(+-)-(3E,3'E)-(p-Phenylenedimethylidyne)bis[2-oxo-10-bornanesulfonic acid](2-Hydroxy-4-methoxyphenyl)(2-hydroxyphenyl)methanone(2-Hydroxy-4-methoxyphenyl)phenylmethanone(±)-3-(p-Methylbenzylidene)camphor1,7,7-Trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one1-(p-tert-Butylphenyl)-3-(p-methoxyphenyl)-1,3-propanedione1-[4-(1,1-Dimethylethyl)phenyl]-3-(4-methoxyphenyl)-1,3-propanedione2,2'-Dihydroxy-4-methoxybenzophenone2,2'-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)2-(2H-Benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-{1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl}propyl)phenol2-Benzoyl-5-methoxy-1-phenol-4-sulfonic acid2-Cyano-3,3-diphenyl-2-propenoic acid, 2-ethylhexyl ester2-Ethoxyethyl p-methoxycinnamate2-Ethylhexyl p-(dimethylamino)benzoate2-Ethylhexyl p-methoxycinnamate2-Ethylhexyl salicylate2-Ethylhexyl-2-cyano-3,3-diphenylacrylate2-Hydroxy-4-methoxybenzophenone2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid2-Hydroxybenzoic acid 2-ethylhexyl ester2-Hydroxybenzoic acid 3,3,5-trimethylcyclohexyl ester2-Hydroxybenzoic acid, compd. with 2,2',2''-nitrilotris(ethanol) (1:1)2-Phenyl-1H-benzimidazole-5-sulphonic acid2-Phenylbenzimidazole-5-sulfonic acid3,3'-(1,4 Phenylenedimethylidene)bis(7,7-dimethyl-2-oxobicyclo[2.2.1]heptane-1- methanesulfonic acid)3,3,5-Trimethylcyclohexyl salicylate3-(4-Methoxyphenyl)-2-propenoic acid 2-ethoxyethyl ester3-(4-Methoxyphenyl)-2-propenoic acid, 2-ethylhexyl ester3-(4-Methoxyphenyl)-2-propenoic acid, compd. with 2,2'-iminobis(ethanol) (1:1)3-Benzoyl-4-hydroxy-6-methoxybenzenesulfonic acid4-(Dimethylamino)benzoic acid, 2-ethylhexyl ester4-tert-Butyl-4'-methoxydibenzoylmethane5-Benzoyl-4-hydroxy-2-methoxybenzenesulfonic acid5-Methyl-2-(1-methylethyl)cyclohexanol 2-aminobenzoateAnthranilic acid, p-menth-3-yl esterAvobenzoneBemotrizinolBenzophenone-3Benzophenone-4Benzophenone-8BisoctrizoleC.I. No. 77891CinoxateDEA-methoxycinnamateDiethanolamine methoxycinnamateDioxybenzoneDrometrizole trisiloxaneEcamsuleEnsulizoleEnzacameneHomomenthyl salicylateHomosalateMenthyl anthranilateMeradimateOctinoxateOctisalateOctocrileneOctocryleneOctyl methoxycinnamateOxybenzonePadimate OSalicylic acid 3,3,5-trimethylcyclohexyl esterSalicylic acid, compound with 2,2',2''-nitrilotriethanol (1:1)SulisobenzoneTerephthalylidene dicamphor sulfonic acidTerephthalylidene-3,3'-dicamphor-10,10'-disulfonic acidTitanic anhydrideTitanium dioxideTitanium dioxide 5Triethanolamine salicylateTrolamine salicylateZinc oxide 6p-Methoxycinnamic acid, compound with 2,2'-iminodiethanol (1:1)

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