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

Warnings

For external use only

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

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

Other Information

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

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

Description

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

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 5%

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

Warnings

For external use only

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

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

Other Information (Other information)

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

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

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 5%

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