4840f608-944a-3e3d-e063-6394a90a1d9d

SPL v1
SPL
SPL Set ID 4840f608-944a-3e3d-e063-6394a90a1d9d
Route
topical
Published
Effective Date 2026-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (2.25 mg) avobenzone (1.25 mg) octocrylene (4.5 mg) homosalate
Inactive Ingredients
cetyl alcohol anhydrous dextrose tocopherol trimethylsiloxysilicate (m/q 1.0-1.2) 1,2-hexanediol trisiloxane butyloctyl salicylate peg-100 stearate polyacrylate-13 c12-20 alkyl glucoside butylene glycol diphenylsiloxy phenyl trimethicone polyisobutylene (45000 mw) cyclopentasiloxane behenyl alcohol cocoa sorbitan isostearate edetate disodium vinylpyrrolidone/eicosene copolymer c14-22 alcohols polysorbate 20 levant cotton seed silicon dioxide glyceryl stearate potassium cetyl phosphate propanediol water ethylhexylglycerin dimethicone

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-19

Description

Avobenzone 2.5% Homosalate 9.0% Octisalate 4.5% Octocrylene 9.0%


Medication Information

Warnings and Precautions

For external use only

Do not use on damanged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Active Ingredient

Avobenzone 2.5%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 9.0%

Indications and Usage

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.

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Children under 6 months of age : Ask a doctor.

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.

Description

Avobenzone 2.5% Homosalate 9.0% Octisalate 4.5% Octocrylene 9.0%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Water / Aqua / Eau,Propanediol, Butyloctyl Salicylate, Diphenylsiloxy Phenyl Trimethicone, Dimethicone, VP/Eicosene Copolymer, Silica, Trisiloxane, Cyclopentasiloxane, Trimethylsiloxysilicate, 1,2-Hexanediol, Behenyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, C14-22 Alcohols, Cetyl Alcohol, Potassium Cetyl Phosphate, Polyacrylate-13, Polyisobutene, C12-20 Alkyl Glucoside, Butylene Glycol, Disodium EDTA, Ethylhexylglycerin, Polysorbate 20, Sorbitan Isostearate, Dextrin, Theobroma Cacao (Cocoa) Extract, Gossypium

Herbaceum (Cotton) Extract, Tocopherol

Section 51945-4

Vitamin E

Vitalizing Sunscreen

Tocopherol

SPF 50+ sunscreen contains Vitamin E

to protect your skin from light (UV rays)

and heat (Aging signs) leaving your

skin healthy and moisturized.

SPF50+ BROAD SPECTRUM

50mL /1.69 fl. oz.

COSRX

Section 53413-1
Section 55105-1

Sunscreen

Section 60561-8

Protect the product in this container from excessive heat and direct sun.

Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Do not use on damanged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Active Ingredient (55106-9)

Avobenzone 2.5%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 9.0%

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

Children under 6 months of age : Ask a doctor.

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.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Water / Aqua / Eau,Propanediol, Butyloctyl Salicylate, Diphenylsiloxy Phenyl Trimethicone, Dimethicone, VP/Eicosene Copolymer, Silica, Trisiloxane, Cyclopentasiloxane, Trimethylsiloxysilicate, 1,2-Hexanediol, Behenyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, C14-22 Alcohols, Cetyl Alcohol, Potassium Cetyl Phosphate, Polyacrylate-13, Polyisobutene, C12-20 Alkyl Glucoside, Butylene Glycol, Disodium EDTA, Ethylhexylglycerin, Polysorbate 20, Sorbitan Isostearate, Dextrin, Theobroma Cacao (Cocoa) Extract, Gossypium

Herbaceum (Cotton) Extract, Tocopherol

Section 51945-4 (51945-4)

Vitamin E

Vitalizing Sunscreen

Tocopherol

SPF 50+ sunscreen contains Vitamin E

to protect your skin from light (UV rays)

and heat (Aging signs) leaving your

skin healthy and moisturized.

SPF50+ BROAD SPECTRUM

50mL /1.69 fl. oz.

COSRX

Section 53413-1 (53413-1)
Section 55105-1 (55105-1)

Sunscreen

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun.

Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.


Advanced Ingredient Data


Raw Label Data

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