PRESTIGE JEJU SNAIL EYE- dimethicone cream 
TONYMOLY CO.,LTD

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.

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ACTIVE INGREDIENT

Active Ingredient: Dimethicone 10.18%

INACTIVE INGREDIENT

Inactive Ingredients: Snail Secretion Filtrate, Dipropylene Glycol, Cyclopentasiloxane, Butylene Glycol, Glycerin, Niacinamide, Silica, Trisiloxane, Cetearyl Alcohol, 1,2-Hexanediol, Dicaprylyl Carbonate, Cetearyl Olivate, Sorbitan Olivate, Glyceryl Stearate, PEG-100 Stearate, PCA Dimethicone, PEG-150 Distearate, C14-22 Alcohols, Phenoxyethanol, Stearic Acid, Ammonium Acryloyldimethyltaurate/VP Copolymer, Panthenol, Dimethiconol, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Caprylyl Glycol, C12-20 Alkyl Glucoside, Water, Dimethicone Crosspolymer, PEG-2M, Adenosine, Citrus Limon (Lemon) Peel Oil, Hydrogenated Lecithin, Dipotassium Glycyrrhizate, Citrus Aurantium Dulcis (Orange) Oil, Sucrose Distearate, Ethylhexylglycerin, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Centella Asiatica Extract, Olea Europaea (Olive) Fruit Oil, Opuntia Coccinellifera Fruit Extract, Pinus Sylvestris Leaf Oil, Ficus Carica (Fig) Fruit Extract, Gardenia Florida Fruit Extract, Salvia Sclarea (Clary) Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Gold (CI 77480), Eucalyptus Globulus Leaf Oil, Camellia Japonica Flower Extract, Cinnamomum Camphora (Camphor) Leaf Extract, Camellia Sinensis Leaf Extract, Citrus Unshiu Peel Extract, sh-Octapeptide-4, sh-Decapeptide-7, rh-Oligopeptide-1, rh-Polypeptide-1, rh-Oligopeptide-2, rh-Polypeptide-3, 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 EYE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-317
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone3.05 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Dipropylene Glycol (UNII: E107L85C40)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-317-021 in 1 CARTON07/01/2016
1NDC:59078-317-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/2016
Labeler - TONYMOLY CO.,LTD (688216798)
Registrant - TONYMOLY CO.,LTD (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO.,LTD688216798manufacture(59078-317)

Revised: 7/2016
Document Id: 55749ab6-7372-4751-a2fb-ce13b5da2579
Set id: ed636b49-7680-4361-92a8-52b3959c31c0
Version: 1
Effective Time: 20160729
 
TONYMOLY CO.,LTD