87350-100

87350-100
SPL v1
SPL
SPL Set ID 497c98c3-d809-52e0-e063-6294a90acca2
Route
TOPICAL
Published
Effective Date 2025-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (1.176 g) Homosalate (1.752 g) Avobenzone (0.696 g) Octocrylene (2.16 g)
Inactive Ingredients
Xanthan Gum Glycerin Leontopodium Alpinum Butylene Glycol Butyloctyl Salicylate Silica Ethylhexylglycerin Water Niacinamide Diphenylsiloxy Phenyl Trimethicone Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Madecassoside Cetearyl Glucoside Behenyl Acrylate Polymer Arginine Adenosine Caprylyl Glycol Sodium Hyaluronate 1,2-hexanediol Sorbitan Olivate Centella Asiatica Glutathione Asiaticoside Ethyl Hexanediol Hyaluronic Acid Madecassic Acid Benzyl Glycol Dimethicone/phenyl Vinyl Dimethicone Crosspolymer Cetearyl Alcohol Limosilactobacillus Fermentum Punica Granatum Fruit Juice Dimethylsilanol Hyaluronate Camellia Sinensis Leaf Asiatic Acid Rosa Damascena Flower Dipropylene Glycol Polymethylsilsesquioxane (11 Microns)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-21
Description

Octocrylene 9.00% Homosalate 7.30% Octisalate 4.90% Avobenzone 2.90%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

■ Helps preven 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 ■ 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 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 ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating

Description

Octocrylene 9.00% Homosalate 7.30% Octisalate 4.90% Avobenzone 2.90%

Section 50565-1

■ keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if ■ rash occurs.

Section 50567-7

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

Section 50570-1

Do not use ■ on damaged or broken skin.

Section 51727-6

Water/Aqua, Butyloctyl Salicylate, Dipropylene Glycol, Silica, Nia cinamide, Diphenylsiloxy Phenyl Trimethicone, Sorbitan Olivate, Benzyl Glycol, Cetearyl Glucoside, Polymethylsilsesquioxane, Poly C10-30 Alkyl Acrylate, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Xanthan Gum, Cetearyl Alcohol, Ethylhexylglycerin, Adenosine, Centella Asiatica Extract, Rosa Damascena Flower Extract, Lactobacillus Ferment, Leontopodium Alpinum Callus Culture Extract, Butylene Glycol, Punica Granatum Fruit Extract, Madecassoside, 1,2-Hexanediol, Glycerin, Camellia Sinensis Leaf Water, Glutathione, Asiaticoside, Ethyl Hexanediol, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Madecassic Acid, Sodium Hyaluronate, Asiatic Acid, Hyaluronic Acid, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Caprylyl Glycol, Sodium Hyaluronate DimethyIsilanol, Sodium Acetylated Hyaluronate

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Octocrylene 9.00%

Homosalate 7.30%

Octisalate 4.90%

Avobenzone 2.90%

Section 60561-8

■ protect the product in this container from excessive heat and direct sun.

Structured Label Content

Indications and Usage (34067-9)

■ Helps preven 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 ■ 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 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 ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

■ keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if ■ rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use ■ on damaged or broken skin.

Section 51727-6 (51727-6)

Water/Aqua, Butyloctyl Salicylate, Dipropylene Glycol, Silica, Nia cinamide, Diphenylsiloxy Phenyl Trimethicone, Sorbitan Olivate, Benzyl Glycol, Cetearyl Glucoside, Polymethylsilsesquioxane, Poly C10-30 Alkyl Acrylate, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Xanthan Gum, Cetearyl Alcohol, Ethylhexylglycerin, Adenosine, Centella Asiatica Extract, Rosa Damascena Flower Extract, Lactobacillus Ferment, Leontopodium Alpinum Callus Culture Extract, Butylene Glycol, Punica Granatum Fruit Extract, Madecassoside, 1,2-Hexanediol, Glycerin, Camellia Sinensis Leaf Water, Glutathione, Asiaticoside, Ethyl Hexanediol, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Madecassic Acid, Sodium Hyaluronate, Asiatic Acid, Hyaluronic Acid, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Caprylyl Glycol, Sodium Hyaluronate DimethyIsilanol, Sodium Acetylated Hyaluronate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Octocrylene 9.00%

Homosalate 7.30%

Octisalate 4.90%

Avobenzone 2.90%

Section 60561-8 (60561-8)

■ protect the product in this container from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:27.118567 · Updated: 2026-03-14T23:12:39.597935