SPL v1
SPL
SPL Set ID bc7edb7a-b356-40c2-aa24-472a909a54c5
Route
TOPICAL
Published
Effective Date 2025-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (8 g) Zinc Cation (10 g)
Inactive Ingredients
Aloe Vera Leaf Polysaccharides Water Ascorbic Acid Barium Sulfate Cetostearyl Alcohol Citric Acid Monohydrate Glycerin Glyceryl Monostearate Hydroxyethyl Cellulose, Unspecified Citrus X Limon Flowering Top Oil Potassium Cetyl Phosphate Potassium Sorbate Vitamin A Palmitate Castor Oil Hydrogenated Castor Oil Carnauba Wax Rosa Moschata Oil Sodium Benzoate Sodium Lactate Sorbitan Olivate Soybean Oil .alpha.-tocopherol Acetate Vanilla Planifolia Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-23

Description

Zink Oxide 10 % & Titanium Dioxide 8 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zink Oxide 10 % & Titanium Dioxide 8 %

Uses
  • helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer 
Warnings
  • For external use only.
  • Do not use: on damaged or broken skin.
  • When using this product: keep out of the eyes, rinse with water to remove.
  • Stop using this product if: Rash occurs
Directions
  • Shake well before use.
  • Apply liberally 15 minutes before sun exposure

Reapply

  • after 80 minutes if swimming or sweating
  • immediately after towel drying
  • at least every two hours

Sun protection measures use a broad-spectrum sunscreen with an SPF value of 50 or higher

  • limit time in the sun, especially from 10am - 2pm
  • wear long-sleeve shirts, pants, hats, sunglasses
  • Children under 6 months of age: ask a doctor
Drug Facts

Product Label

Other Information
  • Store at or below 77⁰ F/25⁰C
  • Do not use if seal is broken
  • protect from excessive heat and direct sun
Active Ingredients

Zink Oxide 10 % & Titanium Dioxide 8 %

Inactive Ingredients

Aloe Vera, Aqua, Ascorbic Acid, Barium Sulphate, Cetearyl Alcohol, Citric Acid, Glycerine, Glyceryl Stearate, Hydroxyethyl Cellulose, Citrullus Vulgaris (Kalahari Melon) Oil, Potassium Cetyl Phosphate, Potassium Sorbate, Retinol Palmitate, Ricinus Communis(Castor)Ceed Oil, Hydrogenated Castor Oil, Copernica Cerifera(Carnauba)Wax, Rosehip Fruit Oil, Sodium Benzoate, Sodium Lactate, Sorbitan Olivate, Soybean Oil, Tocopherol, Vanilla Planifolia Fruit Oil

Keep Out of Reach of Children 


Structured Label Content

Uses
  • helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer 
Purpose

Sunscreen

Warnings
  • For external use only.
  • Do not use: on damaged or broken skin.
  • When using this product: keep out of the eyes, rinse with water to remove.
  • Stop using this product if: Rash occurs
Directions
  • Shake well before use.
  • Apply liberally 15 minutes before sun exposure

Reapply

  • after 80 minutes if swimming or sweating
  • immediately after towel drying
  • at least every two hours

Sun protection measures use a broad-spectrum sunscreen with an SPF value of 50 or higher

  • limit time in the sun, especially from 10am - 2pm
  • wear long-sleeve shirts, pants, hats, sunglasses
  • Children under 6 months of age: ask a doctor
Drug Facts

Product Label (Product label)

Other Information
  • Store at or below 77⁰ F/25⁰C
  • Do not use if seal is broken
  • protect from excessive heat and direct sun
Active Ingredients (Active ingredients)

Zink Oxide 10 % & Titanium Dioxide 8 %

Inactive Ingredients (Inactive ingredients)

Aloe Vera, Aqua, Ascorbic Acid, Barium Sulphate, Cetearyl Alcohol, Citric Acid, Glycerine, Glyceryl Stearate, Hydroxyethyl Cellulose, Citrullus Vulgaris (Kalahari Melon) Oil, Potassium Cetyl Phosphate, Potassium Sorbate, Retinol Palmitate, Ricinus Communis(Castor)Ceed Oil, Hydrogenated Castor Oil, Copernica Cerifera(Carnauba)Wax, Rosehip Fruit Oil, Sodium Benzoate, Sodium Lactate, Sorbitan Olivate, Soybean Oil, Tocopherol, Vanilla Planifolia Fruit Oil

Keep Out of Reach of Children  (Keep out of reach of children )


Advanced Ingredient Data


Raw Label Data

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