BIELLEE POLLEN WHITENING WRINKLE TIME REPAIR CREAM- dimethicone cream 
NSB 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

DIMETHICONE 1.00%

Skin Protectant

Temporarily protects chapped or cracked skin
Prevent and protect from the drying effects of wind and cold weather

Apply liberally as needed onto clean facial skin day or night

For external use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

WATER
GLYCERIN
DIPROPYLENE GLYCOL
POLLEN EXTRACT
PENTAERYTHRITYL TETRAISOSTEARATE
HYDROGENATED POLYDECENE
MORINDA CITRIFOLIA FRUIT EXTRACT
BUTYLENE GLYCOL
CAPRYLIC/CAPRIC TRIGLYCERIDE
TRIETHYLHEXANOIN
GLYCERYL STEARATE CITRATE
NIACINAMIDE
CETEARYL ALCOHOL
GLYCERYL STEARATE
BEHENYL ALCOHOL
FRAGRANCE
PEG-100 STEARATE
PHENOXYETHANOL
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
ISOHEXADECANE
ALLANTOIN
XANTHAN GUM
ETHYLHEXYLGLYCERIN
POLYSORBATE80
DISODIUM EDTA
SODIUM HYALURONATE

image description

BIELLEE POLLEN WHITENING WRINKLE TIME REPAIR CREAM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70784-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.5 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
BEE POLLEN (UNII: 3729L8MA2C)  
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
NONI FRUIT (UNII: 7829X3G2X5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DOCOSANOL (UNII: 9G1OE216XY)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ALLANTOIN (UNII: 344S277G0Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70784-002-021 in 1 CARTON06/21/2016
1NDC:70784-002-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/21/2016
Labeler - NSB CO., LTD. (689846922)
Registrant - NSB CO., LTD. (689846922)
Establishment
NameAddressID/FEIBusiness Operations
NSB CO., LTD.689846922manufacture(70784-002)

Revised: 6/2016
Document Id: 6f83dee5-c777-416b-90c6-689740b9377d
Set id: 8ef445cb-ceee-4b9a-a383-6bdd24b9c138
Version: 1
Effective Time: 20160621
 
NSB CO., LTD.