82723-002

82723-002
SPL v3
SPL
SPL Set ID f66f6b73-3119-593d-e053-2995a90a7003
Route
TOPICAL
Published
Effective Date 2022-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24.1 g) Titanium Dioxide (23.9 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

Zinc Oxide 24.1% Titanium Dioxide 23.9%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 24.1% Titanium Dioxide 23.9%

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 50567-7

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

Stop use and ask a doctor if rash occurs.

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.

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 a doctor if rash occurs.

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

Directions

apply liberally 15 minutes before sun exposure.

reapply :after 80 minutes of swimming or sweating.

immediately after towel drying.

at least every 2 hours.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a m. -2 p.m.

wear long-sleeve shirts, pants, hats, and sunglasses.

children under 6 months: ask a doctor.

Do Not Use

Do not use on damaged or broken skin.

Package Label

82723-002-01

Other Information

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

Active Ingredients

Zinc Oxide 24.1%

Titanium Dioxide 23.9%

Inactive Ingredients

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

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

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 50567-7 (50567-7)

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

Stop use and ask a doctor if rash occurs.

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.

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 a doctor if rash occurs.

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

Directions

apply liberally 15 minutes before sun exposure.

reapply :after 80 minutes of swimming or sweating.

immediately after towel drying.

at least every 2 hours.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a m. -2 p.m.

wear long-sleeve shirts, pants, hats, and sunglasses.

children under 6 months: ask a doctor.

Do Not Use (Do not use)

Do not use on damaged or broken skin.

Package Label

82723-002-01

Other Information

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

Active Ingredients

Zinc Oxide 24.1%

Titanium Dioxide 23.9%

Inactive Ingredients

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

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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