SPL v1
SPL
SPL Set ID 44e194cd-ea61-71b3-e063-6394a90ac486
Route
TOPICAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.75 g) Octocrylene (5 g) Homosalate (6.5 g) Octisalate (4.2 g)
Inactive Ingredients
Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-30

Description

Directions · apply liberally 15 minutes before sun exposure. · reapply at least every 2 hours. · use a water-resistant sunscreen if swimming or sweating. · children under 6 months of age: Ask a doctor. 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.

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Directions · apply liberally 15 minutes before sun exposure. · reapply at least every 2 hours. · use a water-resistant sunscreen if swimming or sweating. · children under 6 months of age: Ask a doctor. 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.

Pdp

Uses

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.

Warnings

Warnings

· For external use only.

· Do not use on damaged or broken skin.

· Stop use and ask a doctor if rash occurs.

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

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

Inactive Ingredient

Inactive Ingredients

Water, Butyloctyl Salicylate, Glycerin, Behenyl Alcohol, Alcohol Denat., Benzotriazolyl Dodecyl p-Cresol, Caprylyl Methicone, Methyl Methacrylate Crosspolymer, Pentylene Glycol, C30-45 Alkyldimethylsilyl Polypropylsilsesquioxane, 1,2-Hexanediol, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Ethylhexyl Methoxycrylene, Carbomer, Caprylyl Glycol, Tromethamine, Limonene, Ectoin, Polyacrylate Crosspolymer-6, Citronellol, Pelargonium Graveolens Flower Oil, Geraniol, Biosaccharide Gum-1, Disodium EDTA, Linalool, Citrus Aurantium Dulcis (Orange) Peel Oil, Asiaticoside, Madecassic Acid, Asiatic Acid, Ethylhexylglycerin, Ceramide NP, Cholesterol, Palmitic Acid, Butylene Glycol, Panthenol, Propanediol, Sorbitol, Poncirrus Trifoliata Fruit Extract, Aspergillus Ferment, Sodium Hyaluronate

Dosage and Adminstration

Directions

· apply liberally 15 minutes before sun exposure.

· reapply at least every 2 hours.

· use a water-resistant sunscreen if swimming or sweating.

· children under 6 months of age: Ask a doctor. 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.

Keep Out of Reach of Children

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


Structured Label Content

Pdp (PDP)

Uses

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

Warnings

· For external use only.

· Do not use on damaged or broken skin.

· Stop use and ask a doctor if rash occurs.

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

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

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients

Water, Butyloctyl Salicylate, Glycerin, Behenyl Alcohol, Alcohol Denat., Benzotriazolyl Dodecyl p-Cresol, Caprylyl Methicone, Methyl Methacrylate Crosspolymer, Pentylene Glycol, C30-45 Alkyldimethylsilyl Polypropylsilsesquioxane, 1,2-Hexanediol, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Ethylhexyl Methoxycrylene, Carbomer, Caprylyl Glycol, Tromethamine, Limonene, Ectoin, Polyacrylate Crosspolymer-6, Citronellol, Pelargonium Graveolens Flower Oil, Geraniol, Biosaccharide Gum-1, Disodium EDTA, Linalool, Citrus Aurantium Dulcis (Orange) Peel Oil, Asiaticoside, Madecassic Acid, Asiatic Acid, Ethylhexylglycerin, Ceramide NP, Cholesterol, Palmitic Acid, Butylene Glycol, Panthenol, Propanediol, Sorbitol, Poncirrus Trifoliata Fruit Extract, Aspergillus Ferment, Sodium Hyaluronate

Dosage and Adminstration (Dosage and adminstration)

Directions

· apply liberally 15 minutes before sun exposure.

· reapply at least every 2 hours.

· use a water-resistant sunscreen if swimming or sweating.

· children under 6 months of age: Ask a doctor. 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.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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


Advanced Ingredient Data


Raw Label Data

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