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Name:Biowhite Brighteningessence
Manufacturer:Zion Synthetic Fiber Co., Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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 Type HUMAN OTC DRUG Item Code (Source) NDC:44781-160
Route of Administration CUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 0.5 mL  in 50 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Butylene Glycol  
Glycerin  
GLYCERYL MONOSTEARATE  
Cetyl Alcohol  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44781-160-01 50 mL in 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 04/01/2010

Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Establishment
Name Address ID/FEI Operations
ZION SYNTHETIC FIBER CO., LTD. 688011147 manufacture

Revised: 04/2011 ZION SYNTHETIC FIBER CO., LTD.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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