TONYMOLY INTENSE CARE GOLD 24K SNAIL- 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.

----------

ACTIVE INGREDIENT

Active Ingredient: Dimethicone 1%

INACTIVE INGREDIENT

Inactive Ingredients:
Snail Secretion Filtrate, Butylene Glycol, Glycerin, Propanediol, Glycereth-26, Niacinamide, Methyl Gluceth-20, Cetyl Ethylhexanoate, Cyclopentasiloxane, Water, Polysorbate 60, Hydrogenated Polydecene, Glyceryl Stearate, Microcrystalline Wax, Cyclohexasiloxane, Carbomer, PEG-100 Stearate, Tromethamine, Ceresin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Chlorphenesin, Caprylyl Glycol, Ethylhexylglycerin, Dimethicone, Glyceryl Polyacrylate, Citrus Medica Limonum (Lemon) Peel Oil, Citrus Unshiu Fruit Extract, Adenosine, Titanium Dioxide (CI 77891), Panax Ginseng Callus Culture Extract, Viscum Album (Mistletoe) Extract, Sasa Quelpaertensis Extract, Nelumbo Nucifera Leaf Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Disodium EDTA, Mica (CI 77019), Morus Bombycis Leaf Extract, Volcanic Ash, Citrus aurantium dulcis (orange) peel oil, Artemisia Vulgaris Extract, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, 1,2-Hexanediol, Gold, Iron Oxides, Eucalyptus Globulus Leaf Oil, Aureobasidium Pullulans Ferment, Xanthan Gum, Opuntia Coccinellifera Fruit Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Lecithin, Usnea Barbata (Lichen) Extract, Sodium Hyaluronate, Glycine Soja (Soybean) Oil, Sodium Ascorbyl Phosphate, Acetyl Heptapeptide-9, Colloidal Gold, rh-Oligopeptide-1

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warning:
1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children

INDICATIONS AND USAGE

Indications and usage:
Take one pearl size amount on cheeks, forehead and chin and spread following the skin texture.
Tap lightly for better absorption.

DOSAGE AND ADMINISTRATION

Dosage and administration:
Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

TONYMOLY INTENSE CARE GOLD 24K SNAIL 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-045
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.45 mg  in 45 mL
Inactive Ingredients
Ingredient NameStrength
Butylene Glycol (UNII: 3XUS85K0RA)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-045-0145 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/2014
Labeler - TONYMOLY CO., LTD. (688216798)
Registrant - TONYMOLY CO., LTD. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO., LTD.688216798manufacture(59078-045)

Revised: 6/2014
Document Id: 125afb33-ecb3-4464-acb2-76a756ea3002
Set id: cf1e0737-cc6c-4296-bf3e-6aa9fc80e9ce
Version: 1
Effective Time: 20140625
 
TONYMOLY CO., LTD.