Label: MELA DEFENSE WHITE ESSENCE- dimethicone gel
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Contains inactivated NDC Code(s)
NDC Code(s): 57718-120-01, 57718-120-02 - Packager: MIZON CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 7, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MELA DEFENSE WHITE ESSENCE
dimethicone gelProduct 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)