83447-002

83447-002
SPL v3
SPL
SPL Set ID 062be336-2af4-10e2-e063-6294a90a480a
Route
CUTANEOUS
Published
Effective Date 2023-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (12 g)
Inactive Ingredients
Sodium Chloride Silicon Dioxide Water Squalane Shea Butter Ethyl Esters Sodium Myristoyl Glutamate Isoamyl Laurate Lecithin, Soybean Aloe Vera Leaf Phenylpropanol Hyaluronic Acid Polyhydroxystearic Acid Stearate Polyglyceryl-3 Ricinoleate Propanediol Niacinamide Aluminum Hydroxide Polyglyceryl-3 Diisostearate Caprylyl Glycol Levomenol Ascorbic Acid Panthenol Tetrasodium Glutamate Diacetate Allantoin Butyloctyl Salicylate Pyridoxine Hydrochloride Methylpropanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-25

Description

Zinc Oxide 25%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 25%

Uses

Helps prevent sunburn

Section 51945-4

Stop Use

Stop use and ask a doctor if rash occurs.

Warnings

Skin Cancer / skin Aging Alert: Spending time in the sun increasesyour risk of skin cancer and early skiraging . This product has been shownonly to help prevent sunburn , not skincancer or early skin aging.

For external use only .

Directions

Apply liberally and evenly 15 minutesbefore sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 months : Ask a doctor.

Do Not Use

Do not use on damaged or broken skin.

Keep Out Of

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

Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Zinc Oxide 25%

Inactive Ingredients

Water , Squalane , Shea Butter EthyEsters , Isoamyl Laurate , Polygly ceryl-3Ricindleate , Buty octyl SalicylatePropanediol , Isopropyl Isostearate ,Polyglyceryl-3 Diisostearate, Methyipropanediol , Niacinamide , SodiumChloride , Lecithin Caprylyl GlycolPanthenol ( itamin B5 ) , Vitamin C , SilicaAloe Barbadensis Leaf Juice PowderBisabolol, Hvdrolvzed SodiumHyaluronate , Allantoin , PhenylpropanolSodium Myristoyl Glutamate , SodiumHyaluronate , Tetrasodium GlutamateDiacetate , Aluminum HydroxidePolyhydroxysteanic Acid

When Using This Product

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


Structured Label Content

Uses

Helps prevent sunburn

Section 51945-4 (51945-4)

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs.

Warnings

Skin Cancer / skin Aging Alert: Spending time in the sun increasesyour risk of skin cancer and early skiraging . This product has been shownonly to help prevent sunburn , not skincancer or early skin aging.

For external use only .

Directions

Apply liberally and evenly 15 minutesbefore sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 months : Ask a doctor.

Do Not Use (Do not use)

Do not use on damaged or broken skin.

Keep Out Of (Keep out of)

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

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Zinc Oxide 25%

Inactive Ingredients (Inactive ingredients)

Water , Squalane , Shea Butter EthyEsters , Isoamyl Laurate , Polygly ceryl-3Ricindleate , Buty octyl SalicylatePropanediol , Isopropyl Isostearate ,Polyglyceryl-3 Diisostearate, Methyipropanediol , Niacinamide , SodiumChloride , Lecithin Caprylyl GlycolPanthenol ( itamin B5 ) , Vitamin C , SilicaAloe Barbadensis Leaf Juice PowderBisabolol, Hvdrolvzed SodiumHyaluronate , Allantoin , PhenylpropanolSodium Myristoyl Glutamate , SodiumHyaluronate , Tetrasodium GlutamateDiacetate , Aluminum HydroxidePolyhydroxysteanic Acid

When Using This Product (When using this product)

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


Advanced Ingredient Data


Raw Label Data

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