00bf17c2-d1fb-4f1f-b30b-519aa80fef5c

Drug Facts

Composition & Product

Active Ingredients

octocrylene (0.47 g) homosalate (0.42 g) octisalate (0.38 g) avobenzone (0.33 g) octinoxate

Inactive Ingredients

dimethicone ethylhexyl palmitate

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2018-03-01

Medication Information

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

Purpose

Purpose: Sunscreen

Description

Uses:

- helps prevent sunburn

- If used as directed with other sun protection measures

Directions:

Take an appropriate amount, evenly apply to face and body anywhere to be exposed to UV rays. Use as the last step of basic skin care.

Active Ingredient

Active ingredients: Octocrylene 5.00%, Homosalate 5.00%, Ethylhexyl Salicylate 4.50%, Butyl Methoxydibenzoylmethane 4.00%, Ethylhexyl Methoxycinnamate 3.50%

Inactive Ingredient

Inactive ingredients:

Dimethicone, Polyethylene, Ethylhexyl Palmitate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Diphenylsiloxy Phenyl Trimethicone, Microcrystalline Wax, Polysilicone-15, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Fragrance, Tocopheryl Acetate, Caprylyl Glycol, Eclipta Prostrata Extract, Melia Azadirachta Leaf Extract, Moringa Oleifera Seed Oil, Water, Panthenol, Calamine, Nelumbo Nucifera Flower Water, Sea Water, Centella Asiatica Extract, 1,2-Hexanediol, Algae Extract, Chlorella Vulgaris Extract, Hizikia Fusiforme Extract, Hydrolyzed Collagen

Package Label.principal Display Panel

Structured Label Content

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

Purpose (PURPOSE)

Purpose: Sunscreen

Description (DESCRIPTION)

Uses:

- helps prevent sunburn

- If used as directed with other sun protection measures

Directions:

Take an appropriate amount, evenly apply to face and body anywhere to be exposed to UV rays. Use as the last step of basic skin care.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Octocrylene 5.00%, Homosalate 5.00%, Ethylhexyl Salicylate 4.50%, Butyl Methoxydibenzoylmethane 4.00%, Ethylhexyl Methoxycinnamate 3.50%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Dimethicone, Polyethylene, Ethylhexyl Palmitate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Diphenylsiloxy Phenyl Trimethicone, Microcrystalline Wax, Polysilicone-15, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Fragrance, Tocopheryl Acetate, Caprylyl Glycol, Eclipta Prostrata Extract, Melia Azadirachta Leaf Extract, Moringa Oleifera Seed Oil, Water, Panthenol, Calamine, Nelumbo Nucifera Flower Water, Sea Water, Centella Asiatica Extract, 1,2-Hexanediol, Algae Extract, Chlorella Vulgaris Extract, Hizikia Fusiforme Extract, Hydrolyzed Collagen

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

Advanced Ingredient Data

[{"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "0.47", "strengthDenominator": "9.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "0.47", "strengthDenominator": "9.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "0.42", "strengthDenominator": "9.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "0.38", "strengthDenominator": "9.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "0.33", "strengthDenominator": "9.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "Dimethicone", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Ethylhexyl Palmitate", "unii": "2865993309", "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: Take an appropriate amount, evenly apply to face and body anywhere to be exposed to UV rays. Use as the last step of basic skin care.", "ACTIVE INGREDIENT": "Active ingredients: Octocrylene 5.00%, Homosalate 5.00%, Ethylhexyl Salicylate 4.50%, Butyl Methoxydibenzoylmethane 4.00%, Ethylhexyl Methoxycinnamate 3.50%", "INACTIVE INGREDIENT": "Inactive ingredients: Dimethicone, Polyethylene, Ethylhexyl Palmitate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Diphenylsiloxy Phenyl Trimethicone, Microcrystalline Wax, Polysilicone-15, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Fragrance, Tocopheryl Acetate, Caprylyl Glycol, Eclipta Prostrata Extract, Melia Azadirachta Leaf Extract, Moringa Oleifera Seed Oil, Water, Panthenol, Calamine, Nelumbo Nucifera Flower Water, Sea Water, Centella Asiatica Extract, 1,2-Hexanediol, Algae Extract, Chlorella Vulgaris Extract, Hizikia Fusiforme Extract, Hydrolyzed Collagen"}