Drug Facts

Composition & Product

Active Ingredients

Avobenzone (3 mL) Homosalate (13 mL) Octisalate (5 mL) Octocrylene (7 mL) Oxybenzone (4 mL)

Inactive Ingredients

Water Sorbitol Stearic Acid Trolamine Aluminum Starch Octenylsuccinate Benzyl Alcohol Sorbitan Isostearate Dimethicone Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Tocopherol Edetate Disodium Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2012-01-01

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 13.0% Octisalate 5.0% Octocrylene 7.0% Oxybenzone 4.0%

Uses

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions ), decrease 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 . May stain some fabrics.

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 13.0%

Octisalate 5.0%

Octocrylene 7.0%

Oxybenzone 4.0%

Inactive Ingredients

Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.

Principal Display Panel

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.

Structured Label Content

Uses

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

Purpose

Sunscreen

Warnings

For external use only. Do not use on damaged or broken skin . May stain some fabrics.

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 13.0%

Octisalate 5.0%

Octocrylene 7.0%

Oxybenzone 4.0%

Inactive Ingredients

Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.

Principal Display Panel

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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decrease the risk of skin cancer and early skin aging caused by the sun.", "Purpose": "Sunscreen", "Warnings": "For external use only. Do not use on damaged or broken skin . May stain some fabrics.", "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 S un 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 13.0% Octisalate 5.0% Octocrylene 7.0% Oxybenzone 4.0%", "Inactive Ingredients": "Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.", "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."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information