SPL v1
SPL
SPL Set ID 2f7225d0-ddfa-e19a-e063-6294a90a52a8
Route
TOPICAL
Published
Effective Date 2025-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (55 mg) Titanium Dioxide (40 mg)
Inactive Ingredients
Aluminum Hydroxide Hexyldecanol Peg-8 Polyhydroxystearic Acid (2300 Mw) Stearic Acid Tocopherol Hexyldecyl Laurate Propylene Glycol Dicaprylate/dicaprate Peg/ppg-15/15 Dimethicone Ethylhexyl Palmitate Polyglyceryl-3 Diisostearate Ceresin Ascorbic Acid Helianthus Annuus (sunflower) Seed Wax Lecithin, Soybean Cetearyl Isononanoate Aluminum Stearate Ethylene Brassylate Cetyl Dimethylbutyl Ether Alumina C12-15 Alkyl Benzoate Citric Acid Zingiber Officinale (ginger) Root Oil Alpha-tocopherol Acetate Ascorbyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-03

Description

Titanium Dioxide 4% Zinc Oxide 5.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 4% Zinc Oxide 5.5%

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.

Section 51945-4

Warning:

Keep out of the reach of children.

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 the reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions:

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating - immediately after towel drying - At least every 2 hours - Children under 6 months: Ask a doctor.

Other Information:

Protect this product from excessive heat and direct sun.

Active Ingredients:

Titanium Dioxide 4% Zinc Oxide 5.5%

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylene Brassylate, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicaprate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil


Structured Label Content

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.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warning:

Keep out of the reach of children.

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 the reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions:

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating - immediately after towel drying - At least every 2 hours - Children under 6 months: Ask a doctor.

Other Information:

Protect this product from excessive heat and direct sun.

Active Ingredients:

Titanium Dioxide 4% Zinc Oxide 5.5%

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylene Brassylate, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicaprate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil


Advanced Ingredient Data


Raw Label Data

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