44e11009-ffcb-dd59-e063-6294a90add22

SPL v2
SPL
SPL Set ID 44e11009-ffcb-dd59-e063-6294a90add22
Route
topical
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (4.5 g) octocrylene (5 g) homosalate (9.5 g) avobenzone (2.7 g)
Inactive Ingredients
water

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
otc monograph drug active Since 2026-01-30

Dosage and Administration

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

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.


Medication Information

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.

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

Dosage and Administration

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.

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

Section 51727-6

Inactive Ingredients

Synthetic Wax, Diethylhexyl Carbonate, Methyl Methacrylate Crosspolymer, Ethylhexyl Isononanoate, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Diphenylsiloxy Phenyl Trimethicone, Diisostearyl Malate, Dimethicone, Phenethyl Benzoate, Dimethiconol, Trisiloxane, Isopropyl Palmitate, Phenyl Propyl Trimethicone, Synthetic Fluorphlogopite, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Polyethylene, Ethylene/Propylene Copolymer, Camellia Japonica Seed Oil, Silica Dimethyl Silylate, Candelilla Wax Esters, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Limonene, Ultramarines (CI 77007), Copernicia Cerifera (Carnauba) Wax, Citronellol, Octyldodecanol, Pelargonium Graveolens Flower Oil, Geraniol, Asiaticoside, Madecassic Acid, Linalool, Citrus Aurantium Dulcis (Orange) Peel Oil, Asiatic Acid, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Neopentyl Glycol Diethylhexanoate, Ceramide NP, Water, Cholesterol, Palmitic Acid, 4-Terpineol, Zinc PCA, Butylene Glycol, 1,2-Hexanediol, Ocimum Sanctum Leaf Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Azadirachta Indica Leaf Extract, Mentha Arvensis Extract, Phenoxyethanol

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

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.

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

Dosage and Administration (Dosage and administration)

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 (PDP)

Section 51727-6 (51727-6)

Inactive Ingredients

Synthetic Wax, Diethylhexyl Carbonate, Methyl Methacrylate Crosspolymer, Ethylhexyl Isononanoate, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Diphenylsiloxy Phenyl Trimethicone, Diisostearyl Malate, Dimethicone, Phenethyl Benzoate, Dimethiconol, Trisiloxane, Isopropyl Palmitate, Phenyl Propyl Trimethicone, Synthetic Fluorphlogopite, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Polyethylene, Ethylene/Propylene Copolymer, Camellia Japonica Seed Oil, Silica Dimethyl Silylate, Candelilla Wax Esters, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Limonene, Ultramarines (CI 77007), Copernicia Cerifera (Carnauba) Wax, Citronellol, Octyldodecanol, Pelargonium Graveolens Flower Oil, Geraniol, Asiaticoside, Madecassic Acid, Linalool, Citrus Aurantium Dulcis (Orange) Peel Oil, Asiatic Acid, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Neopentyl Glycol Diethylhexanoate, Ceramide NP, Water, Cholesterol, Palmitic Acid, 4-Terpineol, Zinc PCA, Butylene Glycol, 1,2-Hexanediol, Ocimum Sanctum Leaf Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Azadirachta Indica Leaf Extract, Mentha Arvensis Extract, Phenoxyethanol

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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