SPL v1
SPL
SPL Set ID 2dcca380-c0e4-4e04-e063-6394a90ac31e
Route
TOPICAL
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 g) Octisalate (5 g) Octocrylene (8 g) Avobenzone (3 g)
Inactive Ingredients
Glycerin Pentylene Glycol Xanthan Gum Benzyl Alcohol Citric Acid Vitis Vinifera (grape) Seed Oil Propanediol Soybean Oil Glyceryl Stearate Se Aloe Barbadensis Leaf Juice Cetearyl Alcohol Water Tocopherol Sunflower Oil Cetearyl Glucoside Potassium Sorbate Prunus Amygdalus Dulcis (sweet Almond) Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 8%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Helps prevent sunburn

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months of age: Ask a doctor

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 8%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product Keep out of eyes. Rinse well with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Aloe Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Pentylene Gycol, Potassium Sorbate, Propanediol, Soybean Oil, Sunflower Oil, Sweet Amond Oil, Tocopherol, Water, Xanthan Gum.

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months of age: Ask a doctor

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 well with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Aloe Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Pentylene Gycol, Potassium Sorbate, Propanediol, Soybean Oil, Sunflower Oil, Sweet Amond Oil, Tocopherol, Water, Xanthan Gum.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)