82723-003

82723-003
SPL v4
SPL
SPL Set ID f6710e0a-e374-96c8-e053-2995a90a11b6
Route
TOPICAL
Published
Effective Date 2022-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (23.9 g) Zinc Oxide (24.1 g)
Inactive Ingredients
Ceramide Np Hyaluronate Sodium Ethyl Acrylate And Methyl Methacrylate Copolymer Dispersion (2:1; 600000 Mw 30% Aqueous) .alpha.-tocopherol Calcium Succinate, Dl-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-07

Description

Titanium Dioxide 23.9% Zinc Oxide 24.1%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 23.9% Zinc Oxide 24.1%

Uses

Uses: Helps prevent sunburn.

Section 50567-7

When using this product keep out of eyes . Rinse with water to remove .

Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .

Stop Use

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes . Rinse with water to remove .

Warnings

For external use only .

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes . Rinse with water to remove .

Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .

Directions

Directions : Apply liberally 15 minutes before sun or water exposure. Works best on moisturized skin.

Reapply:

After 80 minutes of swimming or sweating.

Immediately after towel drying.

At least every 2 hours.

Children under 6 months: Ask a doctor.

Do Not Use

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

Package Label

82723-003-01

Other Information

Other Information : Sun alert : Limiting sun exposure , wearing protective clothing , using sunscreens may reduce the risks of skin aging , skin cancer , and other harmful effects of the sun

Active Ingredients

Titanium Dioxide 23.9%

Zinc Oxide 24.1%

Inactive Ingredients

Inactive Ingredients: Slica , Mica, Polymethyl Methacrylate, Ascorbic Acid (Vitamin C), Ceramide EOP, Sodium Hyaluronate (Hyaluronic Acid), Tocopherol Vitamin E), Camellia Sinensis Leaf Extract, CI 77492, CI 77491

Keep Out of Reach of Children.

Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .


Structured Label Content

Uses

Uses: Helps prevent sunburn.

Section 50567-7 (50567-7)

When using this product keep out of eyes . Rinse with water to remove .

Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes . Rinse with water to remove .

Warnings

For external use only .

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes . Rinse with water to remove .

Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .

Directions

Directions : Apply liberally 15 minutes before sun or water exposure. Works best on moisturized skin.

Reapply:

After 80 minutes of swimming or sweating.

Immediately after towel drying.

At least every 2 hours.

Children under 6 months: Ask a doctor.

Do Not Use (Do not use)

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

Package Label

82723-003-01

Other Information

Other Information : Sun alert : Limiting sun exposure , wearing protective clothing , using sunscreens may reduce the risks of skin aging , skin cancer , and other harmful effects of the sun

Active Ingredients

Titanium Dioxide 23.9%

Zinc Oxide 24.1%

Inactive Ingredients

Inactive Ingredients: Slica , Mica, Polymethyl Methacrylate, Ascorbic Acid (Vitamin C), Ceramide EOP, Sodium Hyaluronate (Hyaluronic Acid), Tocopherol Vitamin E), Camellia Sinensis Leaf Extract, CI 77492, CI 77491

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

Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .


Advanced Ingredient Data


Raw Label Data

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