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

Purpose

Sunscreen

Description

Titanium Dioxide 23.9% Zinc Oxide 24.1%


Medication Information

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 .

Uses

Uses: Helps prevent sunburn.

Purpose

Sunscreen

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.

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

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

Description

Titanium Dioxide 23.9% Zinc Oxide 24.1%

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 .

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

Active Ingredients

Titanium Dioxide 23.9%

Zinc Oxide 24.1%

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

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 .

Uses

Uses: Helps prevent sunburn.

Purpose

Sunscreen

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.

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

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

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 .

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 .

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

Active Ingredients

Titanium Dioxide 23.9%

Zinc Oxide 24.1%

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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