Drug Facts

Composition & Product

Active Ingredients

Avobenzone (3 mL) Homosalate (15 mL) Octisalate (5 mL) Octocrylene (10 mL) Oxybenzone (6 mL)

Inactive Ingredients

Water Glyceryl Monostearate Cellulose, Microcrystalline Butylene Glycol Peg-100 Stearate Benzyl Alcohol Diethylhexyl Syringylidenemalonate Docosanol Palmitic Acid Stearic Acid C12-16 Alcohols Carboxymethylcellulose Sodium Medium-chain Triglycerides Lecithin, Soybean Vitamin A Palmitate Tocopherol Sodium Ascorbyl Phosphate Edetate Disodium Chlorphenesin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2012-01-01

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0% Oxybenzone 6.0%

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 useon damaged or broken skin.

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
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0% Oxybenzone 6.0%

Inactive Ingredients

Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol,Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.

Principle Display Panel

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.

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

Warnings

For external use only. Do not useon damaged or broken skin.

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
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0% Oxybenzone 6.0%

Inactive Ingredients (Inactive ingredients)

Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol,Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.

Principle Display Panel

When Using This Product (When using this product)

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.

Advanced Ingredient Data

[{"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-100 STEARATE", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIETHYLHEXYL SYRINGYLIDENEMALONATE", "unii": "3V5U97P248", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOCOSANOL", "unii": "9G1OE216XY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PALMITIC ACID", "unii": "2V16EO95H1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-16 ALCOHOLS", "unii": "S4827SZE3L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VITAMIN A PALMITATE", "unii": "1D1K0N0VVC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM ASCORBYL PHOSPHATE", "unii": "836SJG51DR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORPHENESIN", "unii": "I670DAL4SZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "Warnings": "For external use only. Do not useon damaged or broken skin.", "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 Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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", "Other Information": "protect this product from excessive heat and direct sun", "Active Ingredients": "Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0% Oxybenzone 6.0%", "Inactive ingredients": "Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol,Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.", "When using this product": "Keep out of eyes. Rinse with water to remove.", "Stop use and ask a doctor": "if rash occurs", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information