SPL v1
SPL
SPL Set ID e3c1d689-36a1-4486-a173-d66e4618118c
Route
TOPICAL
Published
Effective Date 2024-02-01
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 Citrus X Limon Flowering Top Oil Coconut Oil Carnauba Wax Glycerin Glyceryl Monostearate Soybean Oil Hydroxyethyl Cellulose, Unspecified Hydrogenated Castor Oil Ferric Oxide Red Potassium Cetyl Phosphate Potassium Sorbate Vitamin A Palmitate Castor Oil Rosa Moschata Oil Jojoba Oil Sodium Benzoate Hyaluronate Sodium 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
  • Prevents sunburn, Hydrates, Moisturizes and repairs skin with anti-aging properties. Suitable for all skin types.
  • 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
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
  • Apply every morning or 15 min before sun exposure. For dry skin, apply after a layer of moisturizer. Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun protection measures. Use a broad spectrum sunscreen 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℉. Do not use if seal is broken

Active Ingredients 

Zinc Oxide 10%, Titanium Dioxide 8%

Inactive Ingredients

Aqua, Cocos Nucifera Oil, Glycine Soja (Soybean) Oil, Baryte, Glyceryl Stearate, Sorbitan Olivate, Ricinus Communis (Castor) Seed Oil (and) Hydrogenated Castor Oil (and) Copernicia Cerifera (Carnauba) Wax,Hydroxyethyl Cellulose, Cetearyl Alcohol, Glycerine, Simmondsia Chinensis (Jojoba)Seed Oil, Citrullus Vulgaris (Kalahari Melon) Oil, Potassium Cetyl Phosphate, Sodium Lactate, Iron Oxides, Potassium Sorbate, Sodium

Benzoate, Citric Acid, Sodium Hyaluronate (Hyaluronic Acid), Rosa Mosqueta (Rosehip) Fruit Oil, Aloe Barbadensis Leaf Oil, Vanilla Planifolia Fruit Oil, Ascorbic Acid, Tocopherol, Retinol Palmitate


Structured Label Content

Uses
  • Prevents sunburn, Hydrates, Moisturizes and repairs skin with anti-aging properties. Suitable for all skin types.
  • 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
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
  • Apply every morning or 15 min before sun exposure. For dry skin, apply after a layer of moisturizer. Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun protection measures. Use a broad spectrum sunscreen 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℉. Do not use if seal is broken

Active Ingredients  (Active ingredients )

Zinc Oxide 10%, Titanium Dioxide 8%

Inactive Ingredients (Inactive ingredients)

Aqua, Cocos Nucifera Oil, Glycine Soja (Soybean) Oil, Baryte, Glyceryl Stearate, Sorbitan Olivate, Ricinus Communis (Castor) Seed Oil (and) Hydrogenated Castor Oil (and) Copernicia Cerifera (Carnauba) Wax,Hydroxyethyl Cellulose, Cetearyl Alcohol, Glycerine, Simmondsia Chinensis (Jojoba)Seed Oil, Citrullus Vulgaris (Kalahari Melon) Oil, Potassium Cetyl Phosphate, Sodium Lactate, Iron Oxides, Potassium Sorbate, Sodium

Benzoate, Citric Acid, Sodium Hyaluronate (Hyaluronic Acid), Rosa Mosqueta (Rosehip) Fruit Oil, Aloe Barbadensis Leaf Oil, Vanilla Planifolia Fruit Oil, Ascorbic Acid, Tocopherol, Retinol Palmitate


Advanced Ingredient Data


Raw Label Data

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