MOIST MOISTURE- dimethicone emulsion 
Seindni 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 Ingredients: Dimethicone 1%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Snail Secretion Filtrate, Glycerin, Dipropylene Glycol,Hydrogenated Polydecene,Caprylic/Capric Triglyceride,Cetyl Ethylhexanoate,Olea Europaea (Olive) Fruit Oil,Citrus Paradisi (Grapefruit) Fruit Extract, Isostearic Acid,Stearic Acid,PEG-5 Glyceryl Stearate,Glyceryl Stearate SE,Glyceryl Stearate,PEG -100 Stearate,Carbomer,Behenyl Alcohol,Hydrolyzed Collagen,Althaea Rosea Flower Extract,Aloe Barbadensis Leaf Extract,1,2-Hexanediol,Phenoxyethanol,Sodium Polyacrylate,Potassium Hydroxide,Fragrance,Sodium Hyaluronate

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 children: Keep out of reach of babies and children

INDICATIONS AND USAGE

Indication and Usage: Apply appropriate amount on the face after cleansing.

DOSAGE AND ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MOIST MOISTURE 
dimethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69072-090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone2 mg  in 200 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69072-090-01200 mL in 1 CARTON; Type 0: Not a Combination Product06/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2014
Labeler - Seindni Co.,ltd (557837682)
Registrant - Seindni Co.,ltd (557837682)
Establishment
NameAddressID/FEIBusiness Operations
PICOSTECH Co.,Ltd.557816754manufacture(69072-090)

Revised: 5/2019
Document Id: 41c834c9-fc22-4fe4-a63a-959a9282e5e5
Set id: 6d22305f-9310-4d5c-a168-296713b94f9f
Version: 5
Effective Time: 20190530
 
Seindni Co.,ltd