WHITE MINERAL HOMME FLUID- niacinamide emulsion

White Mineral Homme Fluid by

Drug Labeling and Warnings

White Mineral Homme Fluid by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Niacinamide 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, Hydrogenated Poly(C6-14 Olefin), Chondrus Crispus Extract, Saccharum Officinarum (Sugarcane) Extract, Alcohol Denat., Glycerin, Cyclopentasiloxane, Pentylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl, Taurate Copolymer, Dimethicone, Propanediol, Cyclohexasiloxane, Aluminum Starch Octenylsuccinate, Fragrance(Parfum), Polysorbate 60, Phenoxyethanol, Caprylyl Glycol, Sorbitan Sesquioleate, Pyrus Malus (Apple) Fruit Water, Raffinose, Trehalose, Xanthan Gum, Disodium EDTA, Magnesium PCA, Manganese PCA, Sodium PCA, Zinc PCA, Cyclomethicone, Ethylhexylglycerin, Tocopheryl Acetate, Beta-Sitosterol, Panthenol, Propylene Glycol, Ascorbyl Tetraisopalmitate, Cholesterol, Glyceryl Arachidonate, Glyceryl Linoleate, Glyceryl Linolenate, Ubiquinone, Ceteth-24, Choleth-24, Polyglutamic Acid, Potassium Cetyl Phosphate, Sodium Hyaluronate, Biotin, Folic Acid, Pyridoxine

PURPOSE

Purpose: Skin Brightening

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & usage: White Mineral Homme Fluid moisturizes the skin with brightening benefit.

DOSAGE & ADMINISTRATION

Dosage & administration: Dispense an adequate amount after toner and apply gently over the face and lightly pat to help absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WHITE MINERAL HOMME FLUID 
niacinamide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-417
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	2.80 g  in 140 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-417-02	1 in 1 CARTON	12/20/2016
1	NDC: 51346-417-01	140 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/20/2016

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	relabel(51346-417)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(51346-417)