MELA DEFENSE WHITE ESSENCE- dimethicone gel 
MIZON CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ACTIVE INGREDIENT

Active Ingredient: Dimethicone 2.1%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Methyl Gluceth-20, Butylene Glycol, Glycerin, Cyclopentasiloxane, Alcohol, Niacinamide, Bis-Peg-18 Methyl Ether Dimethyl Silane, Dimethicone/Vinyl Dimethicone Crosspolymer, Cyclomethicone, Polysorbate 20, Cyclohexasiloxane, Phenoxyethanol, Microcrystalline Cellulose, Zea Mays (Corn) Starch, Lactose, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Methylparaben, Trehalose, Dimethicone Crosspolymer, Phenyl Trimethicone, Xanthan Gum, Propylparaben, Beta-Glucan, Disodium EDTA, Hydrolyzed Collagen, Tocopheryl Acetate, Cananga Odorata Flower Oil, Rubus Idaeus (Raspberry) Fruit Extract, Pelargonium Graveolens Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Propylene Glycol, Juniperus Mexicana Oil, Eucalyptus Globulus Leaf Oil, Macadamia Integrifolia Seed Oil, Limnanthes Alba(Meadowfoam) Seed Oil, Simmondsia Chinensis(Jojoba) Seed Oil, Ginkgo Biloba Leaf Extract, Sodium Hyaluronate, Coriandrum Sativum (Coriander) Fruit Oil, Gentiana Lutea Root Extract, Prunus Lannesiana Flower Extract, Achillea Millefolium Extract, Oryza Sativa (Rice) Bran Extract, Artemisia Absinthium Extract, Arnica Montana Flower Extract, Hydrolyzed Conchiolin Protein, Hedera Helix(Ivy) Extract, Nelumbo Nucifera Flower Extract, Lilium Candidum Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Convallaria Majalis Bulb/Root Extract, Magnolia Liliflora Flower Extract, Paeonia Lactiflora Root Extract, Potassium Sorbate, Lycium Barbarum Fruit Extract

PURPOSE

Purpose: Skin protectant and brightening

WARNINGS

Warnings: 1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms where product has been applied under direct sunlight. 2. Do not use on scarred skin or if you have dermatitis or eczema. 3. Keep the cap closed on this product. 4. Keep away from direct sunlight or heat. 5. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: Apply an appropriate amount onto cleansed face after use of toner, dabbing until absorbed.

DOSAGE & ADMINISTRATION

Dosage & Administration: Use twice or three times a week.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MELA DEFENSE WHITE ESSENCE 
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.05 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Methyl Gluceth-20 (UNII: J3QD0LD11P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57718-120-021 in 1 CARTON03/02/2016
1NDC:57718-120-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/02/2016
Labeler - MIZON CO., LTD. (557815570)
Registrant - MIZON CO., LTD. (557815570)
Establishment
NameAddressID/FEIBusiness Operations
MIZON CO., LTD.557815570repack(57718-120)
Establishment
NameAddressID/FEIBusiness Operations
Coson Co., Ltd.689835593manufacture(57718-120)

Revised: 4/2016
Document Id: 87cce6cd-55eb-492d-a5ab-62a1100632f7
Set id: 098f21a1-7bc8-49ea-8804-cad310d3136e
Version: 1
Effective Time: 20160407
 
MIZON CO., LTD.