PRESTIGE JEJU SNAIL- glycerin, niacinamide emulsion 
TONYMOLY CO.,LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active Ingredient: Glycerin 8.98%, Niacinamide 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Snail Secretion Filtrate, Water, Hydrogenated Polydecene, Cetyl Ethylhexanoate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cyclopentasiloxane, Macadamia Ternifolia Seed Oil, Cetearyl Alcohol, Hydrogenated Vegetable Oil, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Stearate, Cyclohexasiloxane, Betaine, Palmitic Acid, Carbomer, Polyacrylate-13, Stearic Acid, Tromethamine, Phenoxyethanol, Dimethicone, Tocopheryl Acetate, Chlorphenesin, Polyisobutene, Ethylhexylglycerin, Caprylyl Glycol, Xanthan Gum, Citrus Limon (Lemon) Peel Oil, Lecithin, Adenosine, Polysorbate 20, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Sorbitan Isostearate, Glyceryl Acrylate/Acrylic Acid Copolymer, Disodium EDTA, Rosa Canina Fruit Oil, Citrus aurantium dulcis (orange) peel oil, Citrus Aurantifolia (Lime) Oil, Camellia Japonica Flower Extract, Pinus Sylvestris Leaf Oil, Eucalyptus Globulus Leaf Oil, Gold, Citrus Unshiu Fruit Extract, Dipropylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Ficus Carica (Fig) Fruit Extract, Cinnamomum camphora (camphor) leaf extract, Gardenia Jasminoides Fruit Extract, Opuntia Coccinellifera Fruit Extract, Citric Acid, rh-Polypeptide-22

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only When using this product do not get into eyes, Stop use and ask a doctor if rash occurs Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Use

Use: Helps prevent and relieve chapped or cracked skin

Directions

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

PRESTIGE JEJU SNAIL 
glycerin, niacinamide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-318
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin11.22 g  in 125 mL
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2.50 g  in 125 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-318-021 in 1 CARTON07/01/2016
1NDC:59078-318-01125 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/2016
Labeler - TONYMOLY CO.,LTD (688216798)
Registrant - TONYMOLY CO.,LTD (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO.,LTD688216798manufacture(59078-318)

Revised: 7/2016
Document Id: 8f86b1c0-3de7-4d24-8501-3e7606c8d1d6
Set id: bf97d7b2-fd21-4874-9b07-2bb136a52e0c
Version: 1
Effective Time: 20160729
 
TONYMOLY CO.,LTD