SPL v1
SPL
SPL Set ID 8e295d3d-2748-4f93-9425-de56b5d066d2
Route
TOPICAL
Published
Effective Date 2025-05-22
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 Chamomile Flower Oil 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 prevents 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 eyes.

rinse with water to remove

Stop use and ask doctor if rash occurs

Keep out of reach of children

Direction
  • 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
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, Chamomile, 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


Structured Label Content

Uses

Helps prevents 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 eyes.

rinse with water to remove

Stop use and ask doctor if rash occurs

Keep out of reach of children

Direction
  • 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
Product Label (Product label)

Other Information (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, Chamomile, 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


Advanced Ingredient Data


Raw Label Data

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