Mineral Homme White by The Saem International Co., Ltd.

Mineral Homme White by

Drug Labeling and Warnings

Mineral Homme White by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINERAL HOMME WHITE- niacinamide emulsion 
The Saem International Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active Ingredients: Niacinamide 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Alcohol Denat., Cyclopentasiloxane, Dipropylene Glycol, Cetearyl Alcohol, Cetyl Ethylhexanoate, Stearic Acid, Ethylhexyl Palmitate, Cyclohexasiloxane, Fragrance(Parfum), Glyceryl Stearate, Pentylene Glycol, Polysorbate 60, PEG-60 Hydrogenated Castor Oil, Phenoxyethanol, Dimethicone, Caprylyl Glycol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Isohexadecane, Carbomer, Triethanolamine, Butylene Glycol, Polysorbate 80, Disodium EDTA, Tocopheryl Acetate, Quartz, Macadamia Ternifolia Seed Oil, Phytosphingosine, Pearl Powder, Aqua, Ethylhexylglycerin, Ceramide 3, Magnesium Aspartate, Zinc Gluconate, Pseudoalteromonas Ferment Extract, Sodium Polyacrylate, Xanthan Gum, Hedera Helix (Ivy) Leaf/Stem Extract, Phytic Acid, PEG-8, PPG-1-PEG-9 Lauryl Glycol Ether, Helianthus Annuus (Sunflower) Seed Extract, Copper Gluconate, Serine, Alanine, Proline, Sodium Phosphate, Sodium Hydroxide, Diamond powder

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warning: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children: Keep out of reach of babies and children

INDICATIONS & USAGE

Indication & Usage: Softly apply emulsion along the skin texture and pat gently for better absorption.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

MINERAL HOMME WHITE 
niacinamide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2.6 g  in 130 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-010-01130 mL in 1 CARTON; Type 0: Not a Combination Product12/01/201511/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/201511/01/2019
Labeler - The Saem International Co., Ltd. (689402402)
Registrant - The Saem International Co., Ltd. (689402402)
Establishment
NameAddressID/FEIBusiness Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(70341-010)

Revised: 12/2019
Document Id: 77b440ac-4e0c-493e-930b-376d1fefa8ff
Set id: 0261f5a2-0a1b-49c3-b0ff-8be9e3bc88ff
Version: 2
Effective Time: 20191228
 
The Saem International Co., Ltd.