FDA.reportPublic FDA data

Cellisys EX Wrinkle Solution

Manufacturer
DN Company Co., Ltd. | Cosmax, Inc.
Effective date
2019-03-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:29:05

Label at a glance#

ProductCellisys EX Wrinkle Solution
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

INDICATION AND USAGE: Apply an adequate amount onto the entire face and neck at the last step of skin care.

Dosage and administration

DOSAGE AND ADMINISTRATION: Apply proper amount to the skin.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT: Dimethicone 0.3%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Water, Glycerin, Cyclopentasiloxane, Mineral Oil, Cetearyl Alcohol, Hydrogenated Poly(C6-14 Olefin), Petrolatum, PEG-40 Stearate, Sorbitan Stearate, Stearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Trehalose, Phenoxyethanol, Methylparaben, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Fragrance(Parfum), Triethanolamine, Carbomer, Caprylic/Capric Triglyceride, Alcohol Denat., Propylparaben, Betaine, Macadamia Integrifolia Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ceramide NP, Sodium Polyacrylate, Tocopheryl Acetate, Xanthan Gum, Adenosine, Pseudoalteromonas Ferment Extract, Hydrogenated Lecithin, Disodium EDTA, Butylene Glycol, Argania Spinosa Kernel Oil, Phytosphingosine, BHT, Potassium Cetyl Phosphate, Sodium Hyaluronate, Thermus Thermophillus Ferment, Sodium Ascorbyl Phosphate, Polysorbate 20, Yellow 5 (CI 19140), sh-Oligopeptide-1, Yellow 6 (CI 15985), Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-5, Palmitoyl Tetrapeptide-7

PURPOSE

OTC - PURPOSE SECTION

PURPOSE: Skin protectant, Anti wrinkle

WARNINGS

WARNINGS SECTION

WARNING: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. Keep out of reach of babies and children.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of babies and children.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

INDICATION AND USAGE: Apply an adequate amount onto the entire face and neck at the last step of skin care.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION: Apply proper amount to the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60565-01460565-014-01, 60565-014-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OACTIB

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
97db8b45-7601-4b53-91dc-da6f58926d9c31a15b72-8656-6465-e054-00144ff88e882022-11-10WarningsExact identifier
spl set id: 31a15b72-8656-6465-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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