DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (3.50 g) Octisalate (2.50 g) Zinc Cation (2.40 g) Titanium Dioxide (1.45 g)

Inactive Ingredients

Water Dimethicone

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2017-04-01

Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: - Helps prevent sunburn - Higher SPF gives more sun protection

Directions: - Apply generously and as needed. - Children under 6 months of age : Ask a doctor. - Reapply as needed or after towel drying, swimming or sweating.

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: Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 4.8%, Titanium Dioxide 2.9%

Inactive Ingredient

Inactive ingredients: Water,Cyclopentasiloxane, PEG-10 Dimethicone, Dimethicone,Dipropylene Glycol,Portulaca Oleracea Extract,Magnesium Sulfate,Disteardimonium Hectorite,C30-45 Alkyl Cetearyl Dimethicone Crosspolymer,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,Isoamyl p-Methoxycinnamate,Aluminum Hydroxide,Stearic Acid,Caffeine,Butylene Glycol,Triethoxycaprylylsilane,Disodium EDTA,Phenoxyethanol,Potassium Sorbate,Fragrance(Parfum),Iron Oxides (CI 77491),Iron Oxides (CI 77492)

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 - Higher SPF gives more sun protection

Directions: - Apply generously and as needed. - Children under 6 months of age : Ask a doctor. - Reapply as needed or after towel drying, swimming or sweating.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 4.8%, Titanium Dioxide 2.9%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water,Cyclopentasiloxane, PEG-10 Dimethicone, Dimethicone,Dipropylene Glycol,Portulaca Oleracea Extract,Magnesium Sulfate,Disteardimonium Hectorite,C30-45 Alkyl Cetearyl Dimethicone Crosspolymer,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,Isoamyl p-Methoxycinnamate,Aluminum Hydroxide,Stearic Acid,Caffeine,Butylene Glycol,Triethoxycaprylylsilane,Disodium EDTA,Phenoxyethanol,Potassium Sorbate,Fragrance(Parfum),Iron Oxides (CI 77491),Iron Oxides (CI 77492)

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": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "2.50", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "2.40", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "1.45", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Dimethicone", "unii": "92RU3N3Y1O", "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 - Higher SPF gives more sun protection Directions: - Apply generously and as needed. - Children under 6 months of age : Ask a doctor. - Reapply as needed or after towel drying, swimming or sweating.", "ACTIVE INGREDIENT": "Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 4.8%, Titanium Dioxide 2.9%", "INACTIVE INGREDIENT": "Inactive ingredients: Water,Cyclopentasiloxane, PEG-10 Dimethicone, Dimethicone,Dipropylene Glycol,Portulaca Oleracea Extract,Magnesium Sulfate,Disteardimonium Hectorite,C30-45 Alkyl Cetearyl Dimethicone Crosspolymer,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,Isoamyl p-Methoxycinnamate,Aluminum Hydroxide,Stearic Acid,Caffeine,Butylene Glycol,Triethoxycaprylylsilane,Disodium EDTA,Phenoxyethanol,Potassium Sorbate,Fragrance(Parfum),Iron Oxides (CI 77491),Iron Oxides (CI 77492)"}