Drug Facts

Composition & Product

Active Ingredients

Homosalate (100 mg) Octisalate (50 mg) Octocrylene (40 mg)

Inactive Ingredients

Water Dimethicone Glycerin Propanediol Alcohol Niacinamide Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Peg-30 Dipolyhydroxystearate Tocopherol Disteardimonium Hectorite Magnesium Sulfate, Unspecified Form Phenoxyethanol Disodium Stearoyl Glutamate Aluminum Hydroxide Aloe Vera Leaf Hyaluronate Sodium Brown Iron Oxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-10-01

Medication Information

Purpose

Sunscreen

Description

Homosalate 10% Octisalate 5% Octocrylene 4%

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

Flammable until dry.

Keep away from flames and heat.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water resistant suncreen 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 shrits, pants, hat 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

Homosalate 10%

Octisalate 5%

Octocrylene 4%

Inactive Ingredients

water, dimethicone, glycerin, propanediol, alcohol denat., niacinamide, vinyl dimethicone/methicone silsesquioxane crosspolymer, synthetic fluorphlogopite, PEG-30 dipolyhydroxystearate, tocopherol, disteardimonium hectorite, polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, aloe barbadensis leaf juice powder, sodium hyaluronate; may contain: iron oxides

Questions Or Comments?

1-800-322-2036

Monday-Friday

(10 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

Flammable until dry.

Keep away from flames and heat.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water resistant suncreen 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 shrits, pants, hat 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)

Homosalate 10%

Octisalate 5%

Octocrylene 4%

Inactive Ingredients (Inactive ingredients)

water, dimethicone, glycerin, propanediol, alcohol denat., niacinamide, vinyl dimethicone/methicone silsesquioxane crosspolymer, synthetic fluorphlogopite, PEG-30 dipolyhydroxystearate, tocopherol, disteardimonium hectorite, polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, aloe barbadensis leaf juice powder, sodium hyaluronate; may contain: iron oxides

Questions Or Comments? (Questions or comments?)

1-800-322-2036

Monday-Friday

(10 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

[{"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "100", "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": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPANEDIOL", "unii": "5965N8W85T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER", "unii": "9NH1UDD2RR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-30 DIPOLYHYDROXYSTEARATE", "unii": "9713Q0S7FO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DISTEARDIMONIUM HECTORITE", "unii": "X687XDK09L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM SULFATE, UNSPECIFIED FORM", "unii": "DE08037SAB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DISODIUM STEAROYL GLUTAMATE", "unii": "45ASM2L11M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM HYDROXIDE", "unii": "5QB0T2IUN0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BROWN IRON OXIDE", "unii": "1N032N7MFO", "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 Flammable until dry. Keep away from flames and heat.", "Directions": "For sunscreen use: • apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant suncreen 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 shrits, pants, hat 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": "Homosalate 10% Octisalate 5% Octocrylene 4%", "Inactive ingredients": "water, dimethicone, glycerin, propanediol, alcohol denat., niacinamide, vinyl dimethicone/methicone silsesquioxane crosspolymer, synthetic fluorphlogopite, PEG-30 dipolyhydroxystearate, tocopherol, disteardimonium hectorite, polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, aloe barbadensis leaf juice powder, sodium hyaluronate; may contain: iron oxides", "Questions or comments?": "1-800-322-2036 Monday-Friday (10 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