O2 BUBBLE PACK WASH- dimethicone liquid 
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.

----------

ACTIVE INGREDIENT

Active Ingredients: Dimethicone 1%

INACTIVE INGREDIENT

Inactive Ingredients:
Water,Sodium Laureth Sulfate,Cocamidopropyl,Betaine,Disodium Cocoamphodipropionate,PEG-7 Glyceryl Cocoate,Acrylates Copolymer,Acrylates/Beheneth-25 Methacrylate Copolymer,Methyl Perfluorobutyl Ether,Methyl Perfluoroisobutyl Ether,Polyhydroxystearic Acid,Ethylhexyl Isononanoate,Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate,Isononyl Isononanoate,Snail Secretion Filtrate, Glycerin,Psidium Guajava Fruit Extract,Litchi Chinensis Fruit Extract,Mangifera Indica (Mango) Fruit Extract, Citrus Paradisi (Grapefruit) Fruit Extract,Nephelium Lappaceum Extract,Carica Papaya (Papaya) Fruit Extract,Fragrance,Potassium Alum,Pearl Powder,Xanthan Gum,Potassium Hydroxide,Trisodium EDTA, Papain,Methylchloroisothiazolinone,Methylisothiazolinone

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: After cleansing, pump three times and roll on the dry face avoiding eye area. Rinse off with lukewarm water after 5 minutes.

DOSAGE AND ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

O2 BUBBLE PACK WASH 
dimethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69072-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Betaine (UNII: 3SCV180C9W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69072-030-01100 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(69072-030)

Revised: 12/2018
Document Id: 7cb8dc20-35cf-48f2-acbe-04ab8eb3ad7f
Set id: 5073bdad-2702-4abf-8960-e3582ca131eb
Version: 2
Effective Time: 20181210
 
Seindni Co.,ltd