Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a149b716-58f5-4da1-b330-f79fa7596c18
Route
TOPICAL
Published
Effective Date 2017-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (50.0 mg)
Inactive Ingredients
Ascorbic Acid Ascorbyl Palmitate (c10-c30)alkyl Methacrylate Ester Artemisia Vulgaris Root .beta.-bisabolol Butylene Glycol C13-14 Isoparaffin Camellia Sinensis Flower Medium-chain Triglycerides Caprylyl Glycol Carbomer 934 Cetyl Alcohol Citral Citric Acid Monohydrate Cyclomethicone 6 Cyclomethicone 5 Dimethicone Edetate Disodium Ethylhexylglycerin Glycerin Glyceryl Stearate Se Sunflower Oil Hexylene Glycol Imperata Cylindrica Root Laureth-7 Lecithin, Soybean Limonene, (+)- Peg-100 Stearate Polyethylene Glycol 400 Phenoxyethanol Sorbitan Monostearate Tetrahexyldecyl Ascorbate Tocopherol .alpha.-tocopherol Linoleate, D- Ubiquinone Q2 Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-12

Description

Zinc Oxide - 18.6%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Helps prevent sunburn

if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

apply liberally 20 minutes before sun exposure.

use a water resistant sunscreen if swimming or sweating.

reapply:

immidiately aftr swimming, sweating or towel drying.

at least every 2 hours.

children under 6months: ask doctor

Sun protection measures:

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protector measures including:

limit time in the sun, especially from 10:00 am to 2:00 pm.

wear long sleaved shirts, pants, hats and sun glasses.

Description

Zinc Oxide - 18.6%

Section 50565-1

if product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

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

Section 50570-1

do not use on damaged or broken skin.

Section 51727-6

Ascorbic Acid, Ascorbyl Palmitate, Acrylates/C10-3- Alkyl Acrylate Crosspolymer, Algae Extract, Artemesia Vulgaris Extract, Bisabolol, Butylene Glycol, C13-14 Isoparaffin, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglycerides, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Citral, Citric Acid, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Fragrance*, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Imperata Cylindrica Root Extract, Laureth-7, Lecithin, Limonene, PEG-100 Stearate, PEG-8, Phenoxyethanol, Polyacrylamide Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Linoleate/Oleate, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Obiquinone, Water (Aqua), Xanthan Gum. 100% Natural 

Section 51945-4

Distributed By:

The Soleil Group, LLC.

Bronxville, NY 10708

Energie 43

1271 EC Huizen, Netherlands

www.soleiltoujours.com

MADE IN USA

Section 55106-9

Zinc Oxide - 18.6%

Section 60561-8

May stain or damage some fabrics or surfaces. Avoid long term storage above 40C (120F). Protect the product in this container from excessive heat and direct sunlight.


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

apply liberally 20 minutes before sun exposure.

use a water resistant sunscreen if swimming or sweating.

reapply:

immidiately aftr swimming, sweating or towel drying.

at least every 2 hours.

children under 6months: ask doctor

Sun protection measures:

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protector measures including:

limit time in the sun, especially from 10:00 am to 2:00 pm.

wear long sleaved shirts, pants, hats and sun glasses.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

if product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Ascorbic Acid, Ascorbyl Palmitate, Acrylates/C10-3- Alkyl Acrylate Crosspolymer, Algae Extract, Artemesia Vulgaris Extract, Bisabolol, Butylene Glycol, C13-14 Isoparaffin, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglycerides, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Citral, Citric Acid, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Fragrance*, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Imperata Cylindrica Root Extract, Laureth-7, Lecithin, Limonene, PEG-100 Stearate, PEG-8, Phenoxyethanol, Polyacrylamide Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Linoleate/Oleate, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Obiquinone, Water (Aqua), Xanthan Gum. 100% Natural 

Section 51945-4 (51945-4)

Distributed By:

The Soleil Group, LLC.

Bronxville, NY 10708

Energie 43

1271 EC Huizen, Netherlands

www.soleiltoujours.com

MADE IN USA

Section 55106-9 (55106-9)

Zinc Oxide - 18.6%

Section 60561-8 (60561-8)

May stain or damage some fabrics or surfaces. Avoid long term storage above 40C (120F). Protect the product in this container from excessive heat and direct sunlight.


Advanced Ingredient Data


Raw Label Data

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