Drug Facts

Composition & Product

Active Ingredients

Avobenzone (3.00 mg) Homosalate (15 mg) Octinoxate (7.5 mg) Octisalate (5.00 mg) Octocrylene (10 mg) Oxybenzone (4.00 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-04-29

Medication Information

Purpose

Sunscreen, Sunscreen, Sunscreen, Sunscreen, Sunscreen, Sunscreen,

Description

Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. immediately after towel drying. at least every two hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age; Ask a doctor.

Active Ingredient

Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone

Inactive Ingredients

BHT, C 12- 15 Alkyl Benzoat, Caprylic/Capric Triglyceride, Ceresin, Flavor, Methylparaben, Propylparaben, PVP/Hexadecene Copolymer, Synthetic Beeswax, Tocopherol, Zinc Oxide.

Keep Out of Reach of Children

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

Package/label Principal Display Panel

Structured Label Content

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen, Sunscreen, Sunscreen, Sunscreen, Sunscreen, Sunscreen,

Warnings

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. immediately after towel drying. at least every two hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age; Ask a doctor.

Active Ingredient (Active ingredient)

Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone

Inactive Ingredients

BHT, C 12- 15 Alkyl Benzoat, Caprylic/Capric Triglyceride, Ceresin, Flavor, Methylparaben, Propylparaben, PVP/Hexadecene Copolymer, Synthetic Beeswax, Tocopherol, Zinc Oxide.

Keep Out of Reach of Children

If product is 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": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "3.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "7.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "4.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "15.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "14.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "10.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "IACT", "strengthNumerator": "6.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ALKYL (C12-15) BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "5.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.", "Purpose": "Sunscreen, Sunscreen, Sunscreen, Sunscreen, Sunscreen, Sunscreen,", "Warnings": "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.", "Directions": "Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. immediately after towel drying. at least every two hours. Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age; Ask a doctor.", "Active ingredient": "Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone", "Inactive Ingredients": "BHT, C 12- 15 Alkyl Benzoat, Caprylic/Capric Triglyceride, Ceresin, Flavor, Methylparaben, Propylparaben, PVP/Hexadecene Copolymer, Synthetic Beeswax, Tocopherol, Zinc Oxide.", "Keep Out of Reach of Children": "If product is 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