075dddd5-46ea-282a-e063-6294a90a28fd

SPL v2
SPL
SPL Set ID 075dddd5-46ea-282a-e063-6294a90a28fd
Route
topical
Published
Effective Date 2024-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (15 g) avobenzone (3 g) octocrylene (10 g) octisalate (5 g)
Inactive Ingredients
dimethicone 200 carbomer 940 polyglyceryl-3 distearate trolamine sorbitol water sorbitan isostearate eicosyl povidone stearic acid edetate disodium tocopherol ethylhexylglycerin benzyl alcohol phenoxyethanol aluminum starch octenylsuccinate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-02-28

Description

Avobenzone 3%, Homosalate 15%, Ocitsalate 5%, Octocrylene 10%


Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged or broken skin.

When using this product avoid contact with eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Active Ingredient

Avobenzone 3%, Homosalate 15%, Ocitsalate 5%, Octocrylene 10%

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 and as needed. 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.

Description

Avobenzone 3%, Homosalate 15%, Ocitsalate 5%, Octocrylene 10%

Section 50565-1

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

Section 51727-6

Water, sorbitol, aluminum starch octenylsuccinate, VP/Eicosense copolymer, stearic acid, dimethicone, tocopherol, ethylhexylglycerin, phenoxyethanol, polyglyeryl-3 distearate, sorbitan isostearate, carbomer, disodium EDTA, triethanolamine, benzyl alcohol, fragrance.

Section 51945-4

Section 55105-1

Sunscreen


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged or broken skin.

When using this product avoid contact with eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Active Ingredient (55106-9)

Avobenzone 3%, Homosalate 15%, Ocitsalate 5%, Octocrylene 10%

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 and as needed. 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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water, sorbitol, aluminum starch octenylsuccinate, VP/Eicosense copolymer, stearic acid, dimethicone, tocopherol, ethylhexylglycerin, phenoxyethanol, polyglyeryl-3 distearate, sorbitan isostearate, carbomer, disodium EDTA, triethanolamine, benzyl alcohol, fragrance.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)