BIELLEE POLLEN WHITENING WRINKLE TIME REPAIR SERUM- 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.

----------

Drug Facts

DIMETHICONE 2.55%

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
PROPANEDIOL
BUTYLENE GLYCOL
POLLEN EXTRACT
MACADAMIA TERNIFOLIA SEED OIL
MORINDA CITRIFOLIA FRUIT EXTRACT
CAPRYLIC/CAPRIC TRIGLYCERIDE
NIACINAMIDE
C14-22 ALCOHOLS
PENTAERYTHRITYL TETRAETHYLHEXANOATE
GLYCERIN
BUTYROSPERMUM PARKII (SHEA BUTTER)
GLYCERYL STEARATE
FRAGRANCE
CYCLOPENTASILOXANE
PHENOXYETHANOL
PEG-10 DIMETHICONE
PEG-4 OLIVATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
C12-20 ALKYL GLUCOSIDE
PEG-100 STEARATE
CYCLOHEXASILOXANE
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
HYDROGENATED LECITHIN
XANTHAN GUM
TREHALOSE
ISOHEXADECANE
ETHYLHEXYLGLYCERIN
DISODIUM EDTA
POLYSORBATE80
SODIUM HYALURONATE
GLYCERYL CAPRYLATE

image description

BIELLEE POLLEN WHITENING WRINKLE TIME REPAIR SERUM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70784-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.02 mg  in 40 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
BEE POLLEN (UNII: 3729L8MA2C)  
MACADAMIA OIL (UNII: 515610SU8C)  
NONI FRUIT (UNII: 7829X3G2X5)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
NIACINAMIDE (UNII: 25X51I8RD4)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
GLYCERIN (UNII: PDC6A3C0OX)  
SHEA BUTTER (UNII: K49155WL9Y)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PEG-4 OLEATE (UNII: 9QL37EC4J7)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TREHALOSE (UNII: B8WCK70T7I)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70784-003-021 in 1 CARTON06/22/2016
1NDC:70784-003-0140 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/22/2016
Labeler - NSB CO., LTD. (689846922)
Registrant - NSB CO., LTD. (689846922)
Establishment
NameAddressID/FEIBusiness Operations
NSB CO., LTD.689846922manufacture(70784-003)

Revised: 6/2016
Document Id: 38da8f0e-80bb-450e-b612-6daba06030eb
Set id: 4f5f0ffd-99c0-4b2f-b7e5-e843add0b285
Version: 1
Effective Time: 20160622
 
NSB CO., LTD.