drug facts

Composition & Product

Active Ingredients

avobenzone (30 mg) homosalate (50 mg) octisalate (70 mg) octocrylene

Inactive Ingredients

water glycerin dimethicone

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2016-01-01

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, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, ascorbyl glucoside, benzyl alcohol, benzyl salicylate, butylene glycol, capryloyl salicylic acid, caprylyl glycol, citral, dicaprylyl carbonate, dimethicone/vinyl dimethicone crosspolymer, dipropylene glycol, disodium EDTA, fragrance, geraniol, limonene, linalool, myristic acid, nymphaea alba flower extract, palmitic acid, phenoxyethanol, phenylethyl resorcinol, sodium hyaluronate, sodium hydroxide, sodium palmitoyl proline, steareth-100, stearic acid, t-butyl alcohol, tocopherol, xanthan gum

Description

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

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredient

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Questions Or Comments?

1-800-370-1925

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, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, ascorbyl glucoside, benzyl alcohol, benzyl salicylate, butylene glycol, capryloyl salicylic acid, caprylyl glycol, citral, dicaprylyl carbonate, dimethicone/vinyl dimethicone crosspolymer, dipropylene glycol, disodium EDTA, fragrance, geraniol, limonene, linalool, myristic acid, nymphaea alba flower extract, palmitic acid, phenoxyethanol, phenylethyl resorcinol, sodium hyaluronate, sodium hydroxide, sodium palmitoyl proline, steareth-100, stearic acid, t-butyl alcohol, tocopherol, xanthan gum

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Questions Or Comments? (Questions or comments?)

1-800-370-1925

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

[{"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "Active ingredient": "Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7%", "Other information": "protect the product in this container from excessive heat and direct sun", "Inactive ingredients": "water, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, ascorbyl glucoside, benzyl alcohol, benzyl salicylate, butylene glycol, capryloyl salicylic acid, caprylyl glycol, citral, dicaprylyl carbonate, dimethicone/vinyl dimethicone crosspolymer, dipropylene glycol, disodium EDTA, fragrance, geraniol, limonene, linalool, myristic acid, nymphaea alba flower extract, palmitic acid, phenoxyethanol, phenylethyl resorcinol, sodium hyaluronate, sodium hydroxide, sodium palmitoyl proline, steareth-100, stearic acid, t-butyl alcohol, tocopherol, xanthan gum", "Questions or comments?": "1-800-370-1925", "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."}