DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Homosalate (3.50 g) Octisalate (2.25 g) Ensulizole (1.50 g) Octocrylene (0.50 g)

Inactive Ingredients

Water Butylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2017-08-01

Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: - Helps prevent sunburn - If used as directed with other sun protection measures

Directions: During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet light.

Warnings

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children

Active Ingredient

Active ingredients: Homosalate 7.0%, Ethylhexyl Salicylate 4.5%, Phenylbenzimidazole Sulfonic Acid 3.0%, Octocrylene 1.0%

Inactive Ingredient

Inactive ingredients: Water, Snail Secretion Filtrate, Butylene Glycol, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Butyl Methoxydibenzoylmethane, Silica, Hydrogenated Polydecene, Niacinamide, Dipropylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Polysorbate 60, Dimethicone, Sodium Hydroxide, Caprylyl Glycol, Sorbitan Stearate, Polyacrylate-13, PEG-100 Stearate, Ethylhexylglycerin, Tocopheryl Acetate, Citrus Limon (Lemon) Peel Oil, Polyisobutene, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, BHT, 1,2-Hexanediol, Adenosine, Polysorbate 20, Citrus Aurantium Dulcis (Orange) Peel Oil, Sorbitan Isostearate, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Chamaecyparis Obtusa Water, Eucalyptus Globulus Leaf Oil, Glycerin, Imperata Cylindrica Root Extract, Propanediol, Panthenol, PEG-8, Phenoxyethanol, Carbomer, Centella Asiatica Extract, Carica Papaya (Papaya) Fruit Extract, Aloe Barbadensis Leaf Juice, Beta-Glucan, Potassium Sorbate, Gold, Sodium Benzoate

Package Label.principal Display Panel

Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children

Description (DESCRIPTION)

Uses: - Helps prevent sunburn - If used as directed with other sun protection measures

Directions: During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet light.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Homosalate 7.0%, Ethylhexyl Salicylate 4.5%, Phenylbenzimidazole Sulfonic Acid 3.0%, Octocrylene 1.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Snail Secretion Filtrate, Butylene Glycol, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Butyl Methoxydibenzoylmethane, Silica, Hydrogenated Polydecene, Niacinamide, Dipropylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Polysorbate 60, Dimethicone, Sodium Hydroxide, Caprylyl Glycol, Sorbitan Stearate, Polyacrylate-13, PEG-100 Stearate, Ethylhexylglycerin, Tocopheryl Acetate, Citrus Limon (Lemon) Peel Oil, Polyisobutene, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, BHT, 1,2-Hexanediol, Adenosine, Polysorbate 20, Citrus Aurantium Dulcis (Orange) Peel Oil, Sorbitan Isostearate, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Chamaecyparis Obtusa Water, Eucalyptus Globulus Leaf Oil, Glycerin, Imperata Cylindrica Root Extract, Propanediol, Panthenol, PEG-8, Phenoxyethanol, Carbomer, Centella Asiatica Extract, Carica Papaya (Papaya) Fruit Extract, Aloe Barbadensis Leaf Juice, Beta-Glucan, Potassium Sorbate, Gold, Sodium Benzoate

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

[{"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "3.50", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "2.25", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ENSULIZOLE", "unii": "9YQ9DI1W42", "classCode": "ACTIB", "strengthNumerator": "1.50", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "0.50", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Butylene Glycol", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PURPOSE": "Purpose: Sunscreen", "WARNINGS": "Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children", "DESCRIPTION": "Uses: - Helps prevent sunburn - If used as directed with other sun protection measures Directions: During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet light.", "ACTIVE INGREDIENT": "Active ingredients: Homosalate 7.0%, Ethylhexyl Salicylate 4.5%, Phenylbenzimidazole Sulfonic Acid 3.0%, Octocrylene 1.0%", "INACTIVE INGREDIENT": "Inactive ingredients: Water, Snail Secretion Filtrate, Butylene Glycol, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Butyl Methoxydibenzoylmethane, Silica, Hydrogenated Polydecene, Niacinamide, Dipropylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Polysorbate 60, Dimethicone, Sodium Hydroxide, Caprylyl Glycol, Sorbitan Stearate, Polyacrylate-13, PEG-100 Stearate, Ethylhexylglycerin, Tocopheryl Acetate, Citrus Limon (Lemon) Peel Oil, Polyisobutene, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, BHT, 1,2-Hexanediol, Adenosine, Polysorbate 20, Citrus Aurantium Dulcis (Orange) Peel Oil, Sorbitan Isostearate, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Chamaecyparis Obtusa Water, Eucalyptus Globulus Leaf Oil, Glycerin, Imperata Cylindrica Root Extract, Propanediol, Panthenol, PEG-8, Phenoxyethanol, Carbomer, Centella Asiatica Extract, Carica Papaya (Papaya) Fruit Extract, Aloe Barbadensis Leaf Juice, Beta-Glucan, Potassium Sorbate, Gold, Sodium Benzoate"}