67225-5034

67225-5034
SPL v4
SPL
SPL Set ID 1f9c7718-6fde-236c-e063-6394a90afa19
Route
TOPICAL
Published
Effective Date 2025-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (3.5 g) Octocrylene (4.5 g) Octisalate (2.25 g) Avobenzone (1.35 g)
Inactive Ingredients
Sodium Stearoyl Glutamate Aloe Vera Leaf Polyglycerin-3 Caprylhydroxamic Acid Water Benzotriazolyl Dodecyl P-cresol .alpha.-tocopherol Acetate Propanediol Edetate Disodium Caprylyl Glycol Hyaluronic Acid Glycerin Ceramide Np Microcrystalline Cellulose Cetostearyl Alcohol Alcohol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Rice Bran Panthenol Niacinamide Ammonium Polyacryloyldimethyl Taurate Hydroxyacetophenone Butyloctyl Salicylate Green Tea Leaf Tris(tetramethylhydroxypiperidinol) Citrate Dipropylene Glycol Polyglyceryl-3 Distearate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Butylene Glycol Allantoin Ascorbic Acid Scutellaria Baicalensis Root 1,2-hexanediol Behenyl Acrylate Polymer Carboxymethylcellulose Sodium Tert-butyl Alcohol Saccharomyces Cerevisiae Oleic Acid Silicon Dioxide C13-15 Alkane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-14

Description

Avobenzone 2.70% Homosalate 7.00% Octisalate 4.50% Octocrylene 9.00%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

■ 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.

■ Children under 6 months of age: Ask a doctor.

■ Reapply at least every 2 hours.

■ Use a water-resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. Todecrease 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

Avobenzone 2.70% Homosalate 7.00% Octisalate 4.50% Octocrylene 9.00%

Section 50565-1

If swallowed, get medical help or contact poison control center right away.

Section 50566-9

and ask a doctor if ■ rash occurs.

Section 50567-7

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

Section 50570-1

■ on damaged skin or broken skin

Section 51727-6

Water, Propanediol, Butyloctyl Salicylate, Polyglyceryl-3 Distearate, Silica, Microcrystalline Cellulose, C13-15 Alkane, Panthenol, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Polyglycerin-3, Poly C10-30 Alkyl Acrylate, Dipropylene Glycol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Benzotriazolyl Dodecyl p-Cresol, Hydroxyacetophenone, Sodium Stearoyl Glutamate, Butylene Glycol, Allantoin, Ammonium Polyacryloyldimethyl Taurate, Cetearyl Alcohol, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Glycol, Glycerin, Disodium EDTA, Oleic Acid, Caprylhydroxamic Acid, Ethanol, Cellulose Gum, 1,2-Hexanediol, Oryza Sativa (Rice) Bran Extract, Scutellaria Baicalenesis Root Extract, Tris(Tetramethylhy- droxypiperidinol) Citrate, t-Butyl Alcohol, Ascorbic Acid, Niacinamide, Tocopheryl Acetate, Saccharomyces Cerevisiae Extract, Hyaluronic Acid, Ceramide NP

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 2.70%

Homosalate 7.00%

Octisalate 4.50%

Octocrylene 9.00%

Section 60561-8

■ Protect the product in the container from excessive heat and avoid storing it under direct sun.

■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.


Structured Label Content

Indications and Usage (34067-9)

■ 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.

■ Children under 6 months of age: Ask a doctor.

■ Reapply at least every 2 hours.

■ Use a water-resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. Todecrease 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.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact poison control center right away.

Section 50566-9 (50566-9)

and ask a doctor if ■ rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

■ on damaged skin or broken skin

Section 51727-6 (51727-6)

Water, Propanediol, Butyloctyl Salicylate, Polyglyceryl-3 Distearate, Silica, Microcrystalline Cellulose, C13-15 Alkane, Panthenol, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Polyglycerin-3, Poly C10-30 Alkyl Acrylate, Dipropylene Glycol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Benzotriazolyl Dodecyl p-Cresol, Hydroxyacetophenone, Sodium Stearoyl Glutamate, Butylene Glycol, Allantoin, Ammonium Polyacryloyldimethyl Taurate, Cetearyl Alcohol, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Glycol, Glycerin, Disodium EDTA, Oleic Acid, Caprylhydroxamic Acid, Ethanol, Cellulose Gum, 1,2-Hexanediol, Oryza Sativa (Rice) Bran Extract, Scutellaria Baicalenesis Root Extract, Tris(Tetramethylhy- droxypiperidinol) Citrate, t-Butyl Alcohol, Ascorbic Acid, Niacinamide, Tocopheryl Acetate, Saccharomyces Cerevisiae Extract, Hyaluronic Acid, Ceramide NP

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 2.70%

Homosalate 7.00%

Octisalate 4.50%

Octocrylene 9.00%

Section 60561-8 (60561-8)

■ Protect the product in the container from excessive heat and avoid storing it under direct sun.

■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.


Advanced Ingredient Data


Raw Label Data

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