Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0bb7f0a4-13df-7734-e063-6294a90a242b
Route
TOPICAL
Published
Effective Date 2023-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24 g)
Inactive Ingredients
Quaternium-90 Bentonite Polyglyceryl-3 Pentaricinoleate Aloe Vera Leaf Caprylyl Glycol Medium-chain Triglycerides Butyloctyl Salicylate C13-15 Alkane Stearalkonium Hectorite Candelilla Wax Propylene Carbonate Carnauba Wax Safflower Oil Dimethicone Triethyl Citrate Ethylhexylglycerin Hexylene Glycol Sheanut Isostearic Acid Phenoxyethanol Polymethylsilsesquioxane/trimethylsiloxysilicate Polyhydroxystearic Acid (2300 Mw) Lecithin, Soybean

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-04

Description

Active ingredient, Zinc Oxide – 24 %


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses. Helps prevent sunburn.

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

Dosage and Administration

Directions.

Apply generously and evenly 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 the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use of sunscreen with a broad spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: Ask a doctor.

Description

Active ingredient, Zinc Oxide – 24 %

Section 50565-1

Keep out of reach of children, If product is swallowed, get medical help or contact a poison control center right away.

Section 50566-9

Stop use and ask doctor if skin rash occurs.

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Inactive ingredient:

Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polymethylsilsesquioxane, C13-15Alkane, stearalkonium Hectorite,Propylene Carbonate, Quaternium-90 Bentonite, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera ( Carnauba) Wax, Bytyrospermum Parkii Nut Extract, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Carthamus Tinctorius ( Safflower) Seed Oil, Aloe Barbandensis Leaf Extract, Dimethicon, Triethyl Citrate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol.

Section 51945-4

Section 55105-1

Purpose; Sunscreen

Section 55106-9

Active ingredient,

Zinc Oxide – 24 %

Section 60561-8

Other information.

Protect this product from excessive heat an direct sun.

May stain some fabrics.


Structured Label Content

Indications and Usage (34067-9)

Uses. Helps prevent sunburn.

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

Dosage and Administration (34068-7)

Directions.

Apply generously and evenly 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 the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use of sunscreen with a broad spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: Ask a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children, If product is swallowed, get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor if skin rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Inactive ingredient:

Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polymethylsilsesquioxane, C13-15Alkane, stearalkonium Hectorite,Propylene Carbonate, Quaternium-90 Bentonite, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera ( Carnauba) Wax, Bytyrospermum Parkii Nut Extract, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Carthamus Tinctorius ( Safflower) Seed Oil, Aloe Barbandensis Leaf Extract, Dimethicon, Triethyl Citrate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose; Sunscreen

Section 55106-9 (55106-9)

Active ingredient,

Zinc Oxide – 24 %

Section 60561-8 (60561-8)

Other information.

Protect this product from excessive heat an direct sun.

May stain some fabrics.


Advanced Ingredient Data


Raw Label Data

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