Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0f2b209e-f341-4570-a732-479786e2e8d5
Route
TOPICAL
Published
Effective Date 2017-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (186 mg)
Inactive Ingredients
Water Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Butylene Glycol Glycerin Triepoxycyclohexasilane Glyceryl Stearate Se Peg-100 Stearate Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Sorbitan Monostearate Dimethicone Cetyl Alcohol Teprenone Caprylic/capric/lauric Triglyceride Imperata Cylindrica Root Arabidopsis Thaliana Micrococcus Luteus Phoenix Dactylifera Whole Polygonum Aviculare Whole Sodium Lactate Lecithin, Soybean Tocopherol Citric Acid Acetate Polyacrylamide (10000 Mw) Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Xanthan Gum C13-14 Isoparaffin Laureth-7 Peg-8 Dimethicone Carbomer 934 (c10-c30)alkyl Methacrylate Ester Ascorbyl Palmitate Ascorbic Acid Edetate Disodium

Identifiers & Packaging

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

Description

Active Ingredient: Zinc Oxide - 18.6%


Medication Information

Indications and Usage

Use: Apply to your cleansed and toned face and neck every morning as a daily moisturizer. Re-apply every 2 hours when exposed to sun or as needed.

Dosage and Administration

How to use: Apply to your cleansed and toned face and neck every morning as a daily moisturizer. Re-apply every 2 hours when exposed to sun or as needed.

Description

Active Ingredient: Zinc Oxide - 18.6%

Section 51727-6

Other Ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl, Dimethicone, Sorbitan Stearate, Cetyl Alcohol, Teprenone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylic/Capric Triglyceride, Imperata Cylendrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Lecithin, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/ Oleate, Citric Acid, Polyacrylamide, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerine, Hexylene Glycol, Xanthan Gum, C13-14 Isoparaffin, Laureth-7, PEG-8, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopherol, Asccorbyl Palmitate, Ascorbc Acid, Fragrance, Disodium EDTA.

Section 51945-4

SORELLAAPOTHECARY.COM

Sorella Apothecary, Reno, NV 89509.

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredient:

Zinc Oxide - 18.6%


Structured Label Content

Indications and Usage (34067-9)

Use: Apply to your cleansed and toned face and neck every morning as a daily moisturizer. Re-apply every 2 hours when exposed to sun or as needed.

Dosage and Administration (34068-7)

How to use: Apply to your cleansed and toned face and neck every morning as a daily moisturizer. Re-apply every 2 hours when exposed to sun or as needed.

Section 51727-6 (51727-6)

Other Ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl, Dimethicone, Sorbitan Stearate, Cetyl Alcohol, Teprenone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylic/Capric Triglyceride, Imperata Cylendrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Lecithin, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/ Oleate, Citric Acid, Polyacrylamide, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerine, Hexylene Glycol, Xanthan Gum, C13-14 Isoparaffin, Laureth-7, PEG-8, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopherol, Asccorbyl Palmitate, Ascorbc Acid, Fragrance, Disodium EDTA.

Section 51945-4 (51945-4)

SORELLAAPOTHECARY.COM

Sorella Apothecary, Reno, NV 89509.

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredient:

Zinc Oxide - 18.6%


Advanced Ingredient Data


Raw Label Data

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