SPL v2
SPL
SPL Set ID 3bb6488c-d216-8742-e063-6394a90a16e2
Route
TOPICAL
Published
Effective Date 2025-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (40 mg) Zinc Oxide (55 mg)
Inactive Ingredients
Cetearyl Isononanoate Citric Acid Ethylhexyl Palmitate Cetyl Dimethylbutyl Ether Helianthus Annuus (sunflower) Seed Wax Hexyldecanol Stearic Acid Ci 77491 Ethylene Brassylate Aluminum Hydroxide Hexyldecyl Laurate Ceresin Peg-8 Polyhydroxystearic Acid (2300 Mw) Tocopherol Zingiber Officinale (ginger) Root Oil C12-15 Alkyl Benzoate Ci 77499 Alpha-tocopherol Acetate Aluminum Stearate Ascorbic Acid Peg/ppg-15/15 Dimethicone Ci 77492 Lecithin, Soybean Polyglyceryl-3 Diisostearate Propylene Glycol Dicaprylate/dicaprate Ascorbyl Palmitate Alumina

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-07

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

Purpose:

Sunscreen

Warnings:

For external use only. Do not use on broken or damaged 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 swallowed, get medical help or contact a poison control center right away.

Directions:

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: 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.

Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
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, Iron Oxide, 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

Warnings:

For external use only. Do not use on broken or damaged 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 swallowed, get medical help or contact a poison control center right away.

Directions:

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: 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.

Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
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, Iron Oxide, 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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