Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

Water Propylene Glycol Dicaprylyl Ether Glycerin Peg-100 Stearate Glyceryl Monostearate Squalane Phenoxyethanol Caprylyl Glycol Tocopherol Edetate Disodium Stearic Acid Myristyl Alcohol Almond Oil Apricot Kernel Oil Avocado Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-03-01

Medication Information

Purpose

Sunscreen

Description

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

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 7%

Octisalate 5%

Octocrylene 5%

Inactive Ingredients

water, propylene glycol, dicaprylyl ether, glycerin, PEG-100 stearate, glyceryl stearate, squalane, hydrogenated polyisobutene, phenoxyethanol, sorbitan oleate, caprylyl glycol, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, beeswax, tocopherol, disodium EDTA, stearic acid, myristyl alcohol, prunus amygdalus dulcis (sweet almond) oil, prunus armeniaca (apricol) kernel oil, persea gratissima (avocado) oil

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 7%

Octisalate 5%

Octocrylene 5%

Inactive Ingredients (Inactive ingredients)

water, propylene glycol, dicaprylyl ether, glycerin, PEG-100 stearate, glyceryl stearate, squalane, hydrogenated polyisobutene, phenoxyethanol, sorbitan oleate, caprylyl glycol, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, beeswax, tocopherol, disodium EDTA, stearic acid, myristyl alcohol, prunus amygdalus dulcis (sweet almond) oil, prunus armeniaca (apricol) kernel oil, persea gratissima (avocado) oil

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)

{"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", "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 7% Octisalate 5% Octocrylene 5%", "Inactive ingredients": "water, propylene glycol, dicaprylyl ether, glycerin, PEG-100 stearate, glyceryl stearate, squalane, hydrogenated polyisobutene, phenoxyethanol, sorbitan oleate, caprylyl glycol, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, beeswax, tocopherol, disodium EDTA, stearic acid, myristyl alcohol, prunus amygdalus dulcis (sweet almond) oil, prunus armeniaca (apricol) kernel oil, persea gratissima (avocado) oil", "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."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information