Drug Facts

Composition & Product

Active Ingredients

Octinoxate (4.7 mg) Homosalate (10.50 mg) Octisalate (10.30 mg) Octocrylene (6.90 mg) Zinc Oxide (4 mg)

Inactive Ingredients

Microcrystalline Wax Ceresin Medium-chain Triglycerides Alkyl (c12-15) Benzoate White Wax

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-05-09

Medication Information

Purpose

Sunscreen

Description

Homosalate (6.9%), Octinoxate (4.7%), Octisalate (4.0%), Octocrylene (3.4%), Zinc Oxide (5.0%)

Uses

Helps prevent sunburn.

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 prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts. Keep out of eyes. Rinse with water to remove.

Directions

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.

Active Ingredient

Homosalate (6.9%), Octinoxate (4.7%), Octisalate (4.0%), Octocrylene (3.4%), Zinc Oxide (5.0%)

Inactive Ingredients

BHT, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Flavor Methylparaben, Microcrystalline Wax, Ozokerite, Polyethylene, Propylparaben, PVP/Hexadecene Copolymer, Synthetic Beeswax, Tapioca Starch Polymethylsilsesquioxane, Tocopherol,.

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

Structured Label Content

Uses

Helps prevent sunburn.

Purpose

Sunscreen

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 prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts. Keep out of eyes. Rinse with water to remove.

Directions

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.

Active Ingredient (Active ingredient)

Homosalate (6.9%), Octinoxate (4.7%), Octisalate (4.0%), Octocrylene (3.4%), Zinc Oxide (5.0%)

Inactive Ingredients

BHT, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Flavor Methylparaben, Microcrystalline Wax, Ozokerite, Polyethylene, Propylparaben, PVP/Hexadecene Copolymer, Synthetic Beeswax, Tapioca Starch Polymethylsilsesquioxane, Tocopherol,.

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "4.7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "10.50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "10.30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "6.90", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "3.40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "15.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ALKYL (C12-15) BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "13", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "6.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn.", "Purpose": "Sunscreen", "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 prevent sunburn, not skin cancer or early aging. For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts. Keep out of eyes. Rinse with water to remove.", "Directions": "Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.", "Active ingredient": "Homosalate (6.9%), Octinoxate (4.7%), Octisalate (4.0%), Octocrylene (3.4%), Zinc Oxide (5.0%)", "Inactive Ingredients": "BHT, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Flavor Methylparaben, Microcrystalline Wax, Ozokerite, Polyethylene, Propylparaben, PVP/Hexadecene Copolymer, Synthetic Beeswax, Tapioca Starch Polymethylsilsesquioxane, Tocopherol,.", "Keep Out of Reach of Children": "If swallowed get medical help or contact a Poison Control Center right away."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information