Drug Facts

Composition & Product

Active Ingredients

Avobenzone (30 mg) Homosalate (27 mg) Octisalate (50 mg) Octocrylene (70 mg)

Inactive Ingredients

Water Glycerin Isohexadecane Isononyl Isononanoate Peg-100 Stearate Phenoxyethanol Butylene Glycol Caprylyl Glycol Tocopherol Chlorphenesin Xanthan Gum P-anisic Acid Adenosine Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-12-01

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 2.7% Octisalate 5% Octocrylene 7%

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

Section 51945-4

Warnings

For external use only

Directions

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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 value 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-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

protect the product in this container from excessive heat and direct sun

Active Ingredients

Avobenzone 3%

Homosalate 2.7%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, glycerin, cetearyl alcohol, isohexadecane, glyceryl stearate, cyclohexasiloxane, isononyl isononanoate, butyrospermum parkii (shea) butter, PEG-100 stearate, ceteareth-20, phenoxyethanol, butylene glycol, ammonium polyacryloyldimethyl taurate, caprylyl glycol, tocopherol, chlorphenesin, xanthan gum, disodium EDTA, p-anisic acid, calcium PCA, adenosine, copper PCA, alteromonas ferment extract, corallina officinalis extract, citric acid, sodium hydroxide

Questions Or Comments?

Call toll free 1-800-946-4453

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), decreases the risk of skin cancer and early skin aging caused by the sun

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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 value 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-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 2.7%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, cetearyl alcohol, isohexadecane, glyceryl stearate, cyclohexasiloxane, isononyl isononanoate, butyrospermum parkii (shea) butter, PEG-100 stearate, ceteareth-20, phenoxyethanol, butylene glycol, ammonium polyacryloyldimethyl taurate, caprylyl glycol, tocopherol, chlorphenesin, xanthan gum, disodium EDTA, p-anisic acid, calcium PCA, adenosine, copper PCA, alteromonas ferment extract, corallina officinalis extract, citric acid, sodium hydroxide

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (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)

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Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information