Drug Facts

Composition & Product

Active Ingredients

Avobenzone (22.4 mg) Homosalate (80 mg) Octisalate (24 mg) Octocrylene (44.8 mg) Oxybenzone (28.8 mg)

Inactive Ingredients

Water Alcohol Dimethicone Phenoxyethanol Propylene Glycol Tocopherol Diethylhexyl Syringylidenemalonate Maltodextrin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-02-01

Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.24% Homosalate 8% Octisalate 2.4% Octocrylene 4.48% Oxybenzone 2.88%

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 generously 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 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 2.24%

Homosalate 8%

Octisalate 2.4%

Octocrylene 4.48%

Oxybenzone 2.88%

Inactive Ingredients

water, alcohol denat., dimethicone, cyclopentasiloxane, acrylates/dimethicone copolymer, phenoxyethanol, propylene glycol, capryly glycol, sodium polyacrylate, silica, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, tocopherol, methyl lactate, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

Questions Or Comments?

1-888-LRP-LAB0 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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 generously 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 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 2.24%

Homosalate 8%

Octisalate 2.4%

Octocrylene 4.48%

Oxybenzone 2.88%

Inactive Ingredients (Inactive ingredients)

water, alcohol denat., dimethicone, cyclopentasiloxane, acrylates/dimethicone copolymer, phenoxyethanol, propylene glycol, capryly glycol, sodium polyacrylate, silica, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, tocopherol, methyl lactate, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

Questions Or Comments? (Questions or comments?)

1-888-LRP-LAB0 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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 generously 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 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 2.24% Homosalate 8% Octisalate 2.4% Octocrylene 4.48% Oxybenzone 2.88%", "Inactive ingredients": "water, alcohol denat., dimethicone, cyclopentasiloxane, acrylates/dimethicone copolymer, phenoxyethanol, propylene glycol, capryly glycol, sodium polyacrylate, silica, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, tocopherol, methyl lactate, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin", "Questions or comments?": "1-888-LRP-LAB0 1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)", "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