SPL v4
SPL
SPL Set ID edc89031-7071-4820-a6d1-5b0da9e069c0
Route
TOPICAL
Published
Effective Date 2023-10-18
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 Chamomile Flower Oil Carnauba Wax Castor Oil Cetostearyl Alcohol Ethylhexylglycerin Glycerin 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 2022-08-31

Description

Titanium Dioxide 3.5%, Zinc Oxide 9.5%

Purpose

Topical SPF50 Sun Cream for the prevention of sun burn


Medication Information

Purpose

Topical SPF50 Sun Cream for the prevention of sun burn

Description

Titanium Dioxide 3.5%, Zinc Oxide 9.5%

Uses

Helps prevents 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

Warnings

For external use only

Do not use ondamaged 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 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

Product Label

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, Chamomile Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrogenated Castor Oil, Hydroxyethyl Cellulose, Phenoxyethanol, Rosehip, Soybean Oil, Tocopheryl Acetate, Water, Xanthan Gum


Structured Label Content

Uses

Helps prevents 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

Purpose

Topical SPF50 Sun Cream for the prevention of sun burn

Warnings

For external use only

Do not use ondamaged 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 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

Product Label (Product label)

Other Information (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, Chamomile Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrogenated Castor Oil, Hydroxyethyl Cellulose, Phenoxyethanol, Rosehip, Soybean Oil, Tocopheryl Acetate, Water, Xanthan Gum


Advanced Ingredient Data


Raw Label Data

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