SPL v4
SPL
SPL Set ID 83c6c235-4130-4d6f-b866-66b2ed047059
Route
TOPICAL
Published
Effective Date 2022-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.5 g) Zinc Cation (9.5 g)
Inactive Ingredients
Aloe Vera Leaf Polysaccharides Ascorbic Acid Barium Sulfate Bulbine Frutescens Whole Carnauba Wax Castor Oil Cetostearyl Alcohol Ethylhexylglycerin Glyceryl Monostearate Hydrogenated Castor Oil Hydroxyethyl Cellulose, Unspecified Phenoxyethanol Rosa Moschata Oil Soybean Oil .alpha.-tocopherol Acetate Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-30

Description

Titanium Dioxide 3.5%,   Zinc Oxide 9.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 3.5%,   Zinc Oxide 9.5%

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

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
  • Apply liberally 15 minutes before sun exposure

Reapply

  • after 40 minutes if swimming or sweating
  • immediately after towel drying
  • at least every two hours

Sun protection measuresuse 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

Other Information

store at or below 77℉. Do not use if seal is broken

protect the product in this container from excessive heat and direct sun

Active Ingredients

Titanium Dioxide 3.5%,   Zinc Oxide 9.5%

Inactive Ingredients

Aloe Vera, Ascorbic Acid, Barium Sulphate, Bulbinella, Carnauba, Castor Seed Oil, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrogenated Castor Oil, Hydroxyethyl Cellulose, Phenoxyethanol, Rosehip, Soybean Oil, Tocopheryl Acetate, Water, Xanthan Gum

Keep Out of Reach of Children 

If swallowed, get medical help or contact a poison control center right away.


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 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
  • Apply liberally 15 minutes before sun exposure

Reapply

  • after 40 minutes if swimming or sweating
  • immediately after towel drying
  • at least every two hours

Sun protection measuresuse 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

Other Information

store at or below 77℉. Do not use if seal is broken

protect the product in this container from excessive heat and direct sun

Active Ingredients (Active ingredients)

Titanium Dioxide 3.5%,   Zinc Oxide 9.5%

Inactive Ingredients (Inactive ingredients)

Aloe Vera, Ascorbic Acid, Barium Sulphate, Bulbinella, Carnauba, Castor Seed Oil, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrogenated Castor Oil, Hydroxyethyl Cellulose, Phenoxyethanol, Rosehip, Soybean Oil, Tocopheryl Acetate, Water, Xanthan Gum

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

If swallowed, get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

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