SPL v1
SPL
SPL Set ID 18d8db00-bda8-4670-a3d2-d89a63c5a549
Route
TOPICAL
Published
Effective Date 2024-02-12
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 Water Ascorbic Acid Barium Sulfate Cetostearyl Alcohol Citric Acid Monohydrate Citronella Oil Citrus X Limon Flowering Top Oil Glycerin Glyceryl Monostearate Soybean Oil Hydroxyethyl Cellulose, Unspecified Cymbopogon Citratus Leaf Azadirachta Indica Seed Oil Polysorbate 20 Potassium Cetyl Phosphate Potassium Sorbate Vitamin A Palmitate Castor Oil Hydrogenated Castor Oil Carnauba Wax Rosa Moschata Oil Sodium Benzoate Sodium Lactate Sorbitan Olivate .alpha.-tocopherol Acetate Vanilla Planifolia Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-31

Description

Zinc Oxide 10%, Titanium Dioxide 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc 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 and early skin aging caused by the sun.Repels insects.
Warnings
  • For external use only
  • Do not useon damaged or broken skin
  • When using this productkeep out of eyes ,rinse with water to remove
  • Stop use and ask doctor ifrash occurs
  • Keep out of reach of children
Direction
  • Apply liberally 15 minutes before sun exposure. 
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun protection measures. Use a broad spectrum sun-screen with an SPF value of 50 or higher
  • limit time in the sun, especially from 10 am - 2 pm
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor
Product Label

Other Information
  • store at or below 77° F / 25°C . Do not use if seal is broken
  • protect the product in this container from excessive heat and direact sun
Active Ingredients 

Zinc Oxide 10%, Titanium Dioxide 8%

Inactive Ingredients

Aloe Barbadensis Leaf Oil, Aqua, Ascorbic Acid, Baryte, Cetearyl Alcohol, Citric Acid, Citronella, Citrullus Vulgaris (Kalahari Melon) Oil, Glycerine, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Hydroxyethyl Cellulose, Lemongrass, Neem, Polysorbate 20, Potassium Cetyl Phosphate, Potassium Sorbate, Retinol Palmitate, Ricinus Communis (Castor) Seed Oil (and) Hydrogenated Castor Oil (and) Copernicia Cerifera (Carnauba) Wax, Rosa Mosqueta (Rosehip) Fruit, Sodium Benzoate, Sodium Lactate, Sorbitan Olivate, Tocopheryl Acetate, Vanilla Planifolia Fruit 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.Repels insects.
Purpose

Sunscreen

Warnings
  • For external use only
  • Do not useon damaged or broken skin
  • When using this productkeep out of eyes ,rinse with water to remove
  • Stop use and ask doctor ifrash occurs
  • Keep out of reach of children
Direction
  • Apply liberally 15 minutes before sun exposure. 
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun protection measures. Use a broad spectrum sun-screen with an SPF value of 50 or higher
  • limit time in the sun, especially from 10 am - 2 pm
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor
Product Label (Product label)

Other Information (Other information)
  • store at or below 77° F / 25°C . Do not use if seal is broken
  • protect the product in this container from excessive heat and direact sun
Active Ingredients  (Active ingredients )

Zinc Oxide 10%, Titanium Dioxide 8%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Oil, Aqua, Ascorbic Acid, Baryte, Cetearyl Alcohol, Citric Acid, Citronella, Citrullus Vulgaris (Kalahari Melon) Oil, Glycerine, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Hydroxyethyl Cellulose, Lemongrass, Neem, Polysorbate 20, Potassium Cetyl Phosphate, Potassium Sorbate, Retinol Palmitate, Ricinus Communis (Castor) Seed Oil (and) Hydrogenated Castor Oil (and) Copernicia Cerifera (Carnauba) Wax, Rosa Mosqueta (Rosehip) Fruit, Sodium Benzoate, Sodium Lactate, Sorbitan Olivate, Tocopheryl Acetate, Vanilla Planifolia Fruit Oil


Advanced Ingredient Data


Raw Label Data

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