MELA DEFENSE WHITE ESSENCE- dimethicone gel

MELA DEFENSE WHITE ESSENCE by

Drug Labeling and Warnings

MELA DEFENSE WHITE ESSENCE by is a Otc medication manufactured, distributed, or labeled by MIZON CO., LTD., Coson Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MELA DEFENSE WHITE ESSENCE 
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57718-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	1.05 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Methyl Gluceth-20 (UNII: J3QD0LD11P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57718-120-02	1 in 1 CARTON	03/02/2016
1	NDC: 57718-120-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/02/2016

Labeler - MIZON CO., LTD. (557815570)

Registrant - MIZON CO., LTD. (557815570)

Establishment
Name	Address	ID/FEI	Business Operations
MIZON CO., LTD.		557815570	repack(57718-120)

Establishment
Name	Address	ID/FEI	Business Operations
Coson Co., Ltd.		689835593	manufacture(57718-120)