MELA DEFENSE WHITE ESSENCE

Manufacturer
MIZON CO., LTD. | Coson Co., Ltd.
Effective date
2016-04-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:38

Label at a glance#

ProductMELA DEFENSE WHITE ESSENCE
Active ingredientDimethicone
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Dimethicone 2.1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Skin protectant and brightening

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57718-120-022020-01-31C16284748780-19d75b9d0-a45f-f424-e053-dadaa90a57ce098f21a1-7bc8-49ea-8804-cad310d3136e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57718-120-01MELA DEFENSE WHITE ESSENCE50 mL in 1 BOTTLE, PLASTICGEL501
57718-120-02MELA DEFENSE WHITE ESSENCE1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57718-120MELA DEFENSE WHITE ESSENCE (DIMETHICONE) GEL [MIZON CO., LTD.]1Legacy NDC, 2 package rows20160407_098f21a1-7bc8-49ea-8804-cad310d3136e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57718-12057718-120-01, 57718-120-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
Water059QF0KO0RIACT
Methyl Gluceth-20J3QD0LD11PIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
87cce6cd-55eb-492d-a5ab-62a1100632f7098f21a1-7bc8-49ea-8804-cad310d3136e2016-04-07WarningsExact identifier
spl id: 87cce6cd-55eb-492d-a5ab-62a1100632f7
spl set id: 098f21a1-7bc8-49ea-8804-cad310d3136e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.