BIOWHITE BRIGHTENING ESSENCE- dimethicone cream 
ZION SYNTHETIC FIBER 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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Drug Facts

Active Ingredient: DIMETHICONE

Inactive Ingredients:
Water, Diglycerin, Caprylic Capric Triglyceride, Palmitoyl Pentapeptide-4, C12-15 Alkyl Benzoate, Butylene Glycol, Cetearyl Olivate, Sorbitan Olivate, Propylene Glycol Dicaprylate Dicaprate, Morus Alba Root Extract, Lactoferrin, Glycerin, Tocopheryl Acetate, Beeswax, Glyceryl Stearate, Cetyl Alcohol, Limnanthes Alba (Meadowfoam)Seed Oil, Cyclomethicone, Hydrogenated Lecithin, Alpha-Bisabolol, Sodium Hyaluronate, Lauryl Laurate, Ubiquinone, Polysorbate 20, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Betula Alba Juice, Portulaca Oleracea extract, Calendula Officinalis Flower Extact, Punica Granatum Fruit Extract, Angelica Keiskei Leaf/Stem Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Polygonum Multiflorum Root Extract, Solanum Tuberosum (Potato) Pulp Extract, Artemisia Vulgaris Extract, Vigna Radiata Seed Extract, Gingko Biloba Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract,
Hematite Extract, Aluminum Silicate, Topaz, Amethyst Powder, Zeolite, Isononyl Isononanoate, Triethanolamine, Allantoin, Carbomer, Dipotassium Glycyrrhizate, Disodium EDTA, Xanthan Gum, Methyl Paraben, Phenoxyethanol, Flavor

Purpose:
It prevents skin's spots, blemishes, freckles, and thus, it effects to make skin whitening and brightening.

Warnings:
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.
- In case of having problems such as red rash, swollenness, itching, stimulation during usage.
- In case of having the same symptoms above on the part you put this product on by direct sunlight.
You are banned to use it on the part where you have a scar, eczema, or dermatitis.
In case of getting it into your eyes, you have to wash it immediately.

Keep out of reach of children:
Keep out of the reach of babies and children.

Indication and usage:
Tighten the lid after using it.
Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.
Use it in the morning and evening, after using first Skin Softner and Essential Lotion.

Dosage and administration:
Take up about 0.5g - 1.0g of it, and smooth over the entire face.

Image of carton

BIOWHITE BRIGHTENING  ESSENCE
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-160
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.5 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Glycerin (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44781-160-0150 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2010
Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Establishment
NameAddressID/FEIBusiness Operations
ZION SYNTHETIC FIBER CO., LTD.688011147manufacture

Revised: 4/2011
Document Id: 00e63613-bce5-48ec-9e61-99c2b1e7f263
Set id: cc356529-3483-44d8-b64c-7a5f1e1a3fd4
Version: 1
Effective Time: 20110422
 
ZION SYNTHETIC FIBER CO., LTD.