Label: PERFECT BUST BODY- octinoxate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated May 23, 2012

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  • Active Ingredient

    Octinoxate 7.5%

  • Description

    PERFECT BUST FIRMING CREAM

    SPF 15

    Concentrated cream for daily use. The formula contains a combination of restructuring, toning and reaffirming ingredients (revitalin, structurine, soy) that stimulate cell regeneration and strenghten the dermal fibers by contributing an intense tensor effect and greater solidity to the skin on the bust.

    150ml. 5.1Fl.Oz.



  • Warning

    TOPICAL USE / PROFESSIONAL ONLY

  • Instructions for use

    Apply daily by gently rubbing into the bust and neck with an ascending circular motion.
  • PRINCIPAL DISPLAY PANEL

    PBUST
  • INGREDIENTS AND APPEARANCE
    PERFECT BUST  BODY
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE11.25 mL  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-2 STEARATE (UNII: 94YQ11Y95F)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GERANIOL (UNII: L837108USY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BOMBYX MORI FIBER (UNII: 6LK42KUV6W)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-131-01150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/15/2011
    Labeler - Zenith Medicosm SL (464239694)
    Registrant - Zenith Medicosm SL (464239694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zenith Medicosm SL464239694manufacture
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