47ed3b62-45ef-b67a-e063-6294a90a317b

SPL v1
SPL
SPL Set ID 47ed3b62-45ef-b67a-e063-6294a90a317b
Route
topical
Published
Effective Date 2026-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (135 mg) octisalate (45 mg) octocrylene (90 mg)
Inactive Ingredients
ethylhexylglycerin tocopherol 1,2-hexanediol water panthenol diethylhexyl 2,6-naphthalate glyceryl stearate butyl methoxydibenzoylmethane ammonium acryloyldimethyltaurate/vp copolymer c20-22 alkyl phosphate cetyl alcohol polyacrylate crosspolymer-6 vinylpyrrolidone/eicosene copolymer dipropylene glycol methyl methacrylate/glycol dimethacrylate crosspolymer tromethamine fragrance floral orc0902236 butyloctyl salicylate c20-22 alcohols silica caprylyl methicone pentylene glycol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2026-01-19

Description

Directions Apply liberally 15 minutes before sun exposure 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 10a.m.– 2p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating


Medication Information

Warnings and Precautions

Warnings For external use only.

Do not use on damaged 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.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Active Ingredient

Active Ingredients

Homosalate [13.5%]

Octocrylene [9.0%]

Octisalate [4.5%]

Avobenzone [2.7%]

Indications and Usage

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

Dosage and Administration

Directions

Apply liberally 15 minutes before sun exposure

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 10a.m.– 2p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Description

Directions Apply liberally 15 minutes before sun exposure 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 10a.m.– 2p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients

Water, Homosalate, Octocrylene, Butyloctyl Salicylate, Ethylhexyl Salicylate, Dipropylene Glycol, Butyl Methoxydibenzoylmethane, Panthenol, Diethylhexyl 2,6-Naphthalate, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Silica, Caprylyl Methicone, Pentylene Glycol, Cetyl Alcohol, Methyl Methacrylate Crosspolymer, Glyceryl Stearate, Tromethamine, Polyacrylate Crosspolymer-6, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Fragrance, Ethylhexylglycerin, VP/Eicosene Copolymer, Tocopherol

Section 51945-4

Section 55105-1

Purpose Sunscreen


Structured Label Content

Warnings and Precautions (34071-1)

Warnings For external use only.

Do not use on damaged 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.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Active Ingredient (55106-9)

Active Ingredients

Homosalate [13.5%]

Octocrylene [9.0%]

Octisalate [4.5%]

Avobenzone [2.7%]

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

Apply liberally 15 minutes before sun exposure

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 10a.m.– 2p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Homosalate, Octocrylene, Butyloctyl Salicylate, Ethylhexyl Salicylate, Dipropylene Glycol, Butyl Methoxydibenzoylmethane, Panthenol, Diethylhexyl 2,6-Naphthalate, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Silica, Caprylyl Methicone, Pentylene Glycol, Cetyl Alcohol, Methyl Methacrylate Crosspolymer, Glyceryl Stearate, Tromethamine, Polyacrylate Crosspolymer-6, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Fragrance, Ethylhexylglycerin, VP/Eicosene Copolymer, Tocopherol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)