daf0291e-770c-eaf2-e053-2a95a90a0b67

SPL v6
SPL
SPL Set ID daf0291e-770c-eaf2-e053-2a95a90a0b67
Route
topical
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (1.25 mg) octocrylene (2.25 mg) homosalate (4.5 mg) octisalate
Inactive Ingredients
1,3-propanediol bis(4-aminobenzoate) vinylpyrrolidone/eicosene copolymer 1,2-hexanediol docosanol glyceryl monostearate c14-22 alcohols silicon dioxide trisiloxane cyclomethicone 5 trimethylsiloxysilicate (m/q 1.0-1.2) peg-100 stearate cetyl alcohol ceteth-18 butylene glycol diphenylsiloxy phenyl trimethicone dimethicone echinacea purpurea flowering top water anhydrous dextrose polyisobutylene (45000 mw) edetate disodium ethylhexylglycerin polysorbate 20 sorbitan isostearate cocoa levant cotton seed .alpha.-tocopherol, dl- potassium cetyl phosphate c12-20 alkyl glucoside

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-01

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%

Description

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

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

Section 50567-7

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 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, Fragrance / Parfum, C12-20 Alkyl glucoside, Butylene glycol, Disodium EDTA, Ethylhexylglycerin, Polysorbate 20, Sorbitan isostearate, Dextrin, Theobroma cacao (cocoa) extract, Gossypium herbaceum (cotton) extract, Glucose, 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%

Description (34089-3)

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 50567-7 (50567-7)

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 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, Fragrance / Parfum, C12-20 Alkyl glucoside, Butylene glycol, Disodium EDTA, Ethylhexylglycerin, Polysorbate 20, Sorbitan isostearate, Dextrin, Theobroma cacao (cocoa) extract, Gossypium herbaceum (cotton) extract, Glucose, 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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