47e5198e-7bf6-72a8-e063-6294a90a7ec5

SPL v1
SPL
SPL Set ID 47e5198e-7bf6-72a8-e063-6294a90a7ec5
Route
topical
Published
Effective Date 2024-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (20 g)
Inactive Ingredients
dehydroacetic acid .alpha.-tocopherol acetate phytate sodium glycerin sodium stearoyl glutamate sucrose stearate/palmitate ester (75% mono ester) medium-chain triglycerides panthenol polyhydroxystearic acid (2300 mw) xanthan gum niacinamide glyceryl monostearate coco-caprylate sucrose stearate water citric acid monohydrate saccharide isomerate sucrose laurate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-04

Purpose

Active Ingredients Zinc Oxide 20%..............................................Sunscreen

Description

Zinc Oxide 20%...................Sunscreen


Medication Information

Warnings

For external use only.

Purpose

Active Ingredients

Zinc Oxide 20%..............................................Sunscreen

Inactive Ingredients

Inactive Ingredients

Benzyl Alcohol

Butyloctyl Salicylate

Caprylic/Capric Triglyceride

Citric Acid

Coco-Caprylate

Dehydroacetic Acid

Glycerin

Glyceryl Stearate

Niacinamide

Pathenol

Polyhydroxystearic Acid

Sodium Phytate

Saccharide Isomerate

Sodium Stearoyl Glutamate

Sucrose palmitate-stearate

Sucrose Laurate

Tocopheryl Acetate

Water

Xanthan Gum

Description

Zinc Oxide 20%...................Sunscreen

Section 51945-4

PRINCIPAL DISPLAY PANEL

Stop Use

Stop use and ask a physician if rash occurs.

Do Not Use

Do not use on damaged or broken skin.

When Using

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

Active Ingredient

Zinc Oxide 20%...................Sunscreen

Indications & Usage

Uses helps prevent sunburn.

If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early aging caused by the sun.

Dosage & Administration

Directions

Apply liberally to face and neck 15 minutes before sun exposure.

Use a water-resistant sunscreen if swimming or sweating.

Reapply at least every two 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 broad-spectrum SPF of 15 or

higher and other sun protection measures including

limit time in the sun, especially from 10am - 2pm;

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

Children under 6 months: Ask a physician

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 (WARNINGS)

For external use only.

Purpose (PURPOSE)

Active Ingredients

Zinc Oxide 20%..............................................Sunscreen

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive Ingredients

Benzyl Alcohol

Butyloctyl Salicylate

Caprylic/Capric Triglyceride

Citric Acid

Coco-Caprylate

Dehydroacetic Acid

Glycerin

Glyceryl Stearate

Niacinamide

Pathenol

Polyhydroxystearic Acid

Sodium Phytate

Saccharide Isomerate

Sodium Stearoyl Glutamate

Sucrose palmitate-stearate

Sucrose Laurate

Tocopheryl Acetate

Water

Xanthan Gum

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

Stop Use (STOP USE)

Stop use and ask a physician if rash occurs.

Do Not Use (DO NOT USE)

Do not use on damaged or broken skin.

When Using (WHEN USING)

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

Active Ingredient (ACTIVE INGREDIENT)

Zinc Oxide 20%...................Sunscreen

Indications & Usage (INDICATIONS & USAGE)

Uses helps prevent sunburn.

If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early aging caused by the sun.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Directions

Apply liberally to face and neck 15 minutes before sun exposure.

Use a water-resistant sunscreen if swimming or sweating.

Reapply at least every two 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 broad-spectrum SPF of 15 or

higher and other sun protection measures including

limit time in the sun, especially from 10am - 2pm;

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

Children under 6 months: Ask a physician

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.


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Raw Label Data

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