78b4a13f-5414-4186-8792-58ea0da39bc7

Drug Facts

Composition & Product

Active Ingredients

octinoxate (3.50 g) homosalate (3.00 g) octisalate (2.25 g)

Inactive Ingredients

water glycerin

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2017-08-01

Medication Information

Warnings

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

Purpose

Purpose: Sunscreen

Description

Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Directions: Apply the sun gel liberally to cover all parts of your face and body exposed to the sun's rays.

Active Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Homosalate 6.00%, Ethylhexyl Salicylate 4.50%

Inactive Ingredient

Inactive ingredients: Water, Glycerin, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Alcohol, Niacinamide, Polymethyl Methacrylate, Polymethylsilsesquioxane, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Phenoxyethanol, Fragrance, Fructooligosaccharides, Saccharide Hydrolysate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Propanediol, Pullulan, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Adenosine, Butylene Glycol, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sambucus Nigra Flower Extract, Citrus Aurantium Dulcis (Orange) Flower Extract, Magnolia Liliflora Flower Extract, Plumeria Rubra Flower Extract, Lilium Tigrinum Extract, Glyceryl Stearate, Dimethicone, Carbomer, Polyglyceryl-3 Methylglucose Distearate, Polysorbate 20, Polyacrylate Crosspolymer-6, Titanium Dioxide (CI77891), C12-15 Alkyl Benzoate, Tocopherol, Polyglyceryl-2 Caprate, Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, t-Butyl Alcohol, Stearic Acid, Glyceryl Caprylate, Squalane

Package Label.principal Display Panel

Structured Label Content

Warnings (WARNINGS)

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

Purpose (PURPOSE)

Purpose: Sunscreen

Description (DESCRIPTION)

Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Directions: Apply the sun gel liberally to cover all parts of your face and body exposed to the sun's rays.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Homosalate 6.00%, Ethylhexyl Salicylate 4.50%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Glycerin, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Alcohol, Niacinamide, Polymethyl Methacrylate, Polymethylsilsesquioxane, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Phenoxyethanol, Fragrance, Fructooligosaccharides, Saccharide Hydrolysate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Propanediol, Pullulan, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Adenosine, Butylene Glycol, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sambucus Nigra Flower Extract, Citrus Aurantium Dulcis (Orange) Flower Extract, Magnolia Liliflora Flower Extract, Plumeria Rubra Flower Extract, Lilium Tigrinum Extract, Glyceryl Stearate, Dimethicone, Carbomer, Polyglyceryl-3 Methylglucose Distearate, Polysorbate 20, Polyacrylate Crosspolymer-6, Titanium Dioxide (CI77891), C12-15 Alkyl Benzoate, Tocopherol, Polyglyceryl-2 Caprate, Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, t-Butyl Alcohol, Stearic Acid, Glyceryl Caprylate, Squalane

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

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "3.50", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "3.00", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "2.25", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "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. Replace the cap after use. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.", "DESCRIPTION": "Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun Directions: Apply the sun gel liberally to cover all parts of your face and body exposed to the sun's rays.", "ACTIVE INGREDIENT": "Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Homosalate 6.00%, Ethylhexyl Salicylate 4.50%", "INACTIVE INGREDIENT": "Inactive ingredients: Water, Glycerin, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Alcohol, Niacinamide, Polymethyl Methacrylate, Polymethylsilsesquioxane, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Phenoxyethanol, Fragrance, Fructooligosaccharides, Saccharide Hydrolysate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Propanediol, Pullulan, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Adenosine, Butylene Glycol, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sambucus Nigra Flower Extract, Citrus Aurantium Dulcis (Orange) Flower Extract, Magnolia Liliflora Flower Extract, Plumeria Rubra Flower Extract, Lilium Tigrinum Extract, Glyceryl Stearate, Dimethicone, Carbomer, Polyglyceryl-3 Methylglucose Distearate, Polysorbate 20, Polyacrylate Crosspolymer-6, Titanium Dioxide (CI77891), C12-15 Alkyl Benzoate, Tocopherol, Polyglyceryl-2 Caprate, Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, t-Butyl Alcohol, Stearic Acid, Glyceryl Caprylate, Squalane"}