44e0098c-170f-ca51-e063-6294a90aed20

SPL v1
SPL
SPL Set ID 44e0098c-170f-ca51-e063-6294a90aed20
Route
topical
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (2.8 g) homosalate (7.3 g) octisalate (4.8 g) octocrylene (8.7 g)
Inactive Ingredients
water

Identifiers & Packaging

Pill Appearance
Color: white
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 Panel

Inactive Ingredient

Inactive Ingredients

Water, Isohexadecane, Dipropylene Glycol, Silica, Niacinamide, Polysorbate 80, Propanediol, Pentylene Glycol, Arginine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylene Glycol, Isopentyldiol, Citrus Aurantium Dulcis (Orange) Peel Oil, Methylpropanediol, Xanthan Gum, Glyceryl Glucoside, Polyglycerin-3, 1,2-Hexanediol, Ethylhexylglycerin, Adenosine, Caprylyl Glycol, Glycerin, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Pelargonium Graveolens Flower Oil, Coccinia Indica Fruit Extract, Ilex Paraguariensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Corchorus Olitorius Leaf Extract, Borago Officinalis Extract, Sodium Hyaluronate Crosspolymer, Asiaticoside, Madecassoside, Madecassic Acid, Steareth-30, Solanum Melongena (Eggplant) Fruit Extract, Aloe Barbadensis Flower Extract, Hydrolyzed Glycosaminoglycans, Asiatic Acid, Sorbitan Stearate, Sodium Hyaluronate, Ocimum Sanctum Leaf Extract,

Pseudoalteromonas Ferment Extract, Benzyl Glycol, Curcuma Longa (Turmeric) Root Extract, Corallina Officinalis Extract, Ceramide NP, Hydrolyzed Hyaluronic Acid, Centella Asiatica Extract, Cholesterol, Palmitic acid, Sodium Guaiazulene Sulfonate, Hyaluronic Acid, Sodium DNA, Geraniol, Linalool, Citronellol, Limonene

Dosage and Administrations

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

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

Pdp Panel (PDP PANEL)

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients

Water, Isohexadecane, Dipropylene Glycol, Silica, Niacinamide, Polysorbate 80, Propanediol, Pentylene Glycol, Arginine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylene Glycol, Isopentyldiol, Citrus Aurantium Dulcis (Orange) Peel Oil, Methylpropanediol, Xanthan Gum, Glyceryl Glucoside, Polyglycerin-3, 1,2-Hexanediol, Ethylhexylglycerin, Adenosine, Caprylyl Glycol, Glycerin, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Pelargonium Graveolens Flower Oil, Coccinia Indica Fruit Extract, Ilex Paraguariensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Corchorus Olitorius Leaf Extract, Borago Officinalis Extract, Sodium Hyaluronate Crosspolymer, Asiaticoside, Madecassoside, Madecassic Acid, Steareth-30, Solanum Melongena (Eggplant) Fruit Extract, Aloe Barbadensis Flower Extract, Hydrolyzed Glycosaminoglycans, Asiatic Acid, Sorbitan Stearate, Sodium Hyaluronate, Ocimum Sanctum Leaf Extract,

Pseudoalteromonas Ferment Extract, Benzyl Glycol, Curcuma Longa (Turmeric) Root Extract, Corallina Officinalis Extract, Ceramide NP, Hydrolyzed Hyaluronic Acid, Centella Asiatica Extract, Cholesterol, Palmitic acid, Sodium Guaiazulene Sulfonate, Hyaluronic Acid, Sodium DNA, Geraniol, Linalool, Citronellol, Limonene

Dosage and Administrations (Dosage and administrations)

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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