Label: TENDER MOMENTS BABY BOTTOM BALM- zinc oxide, dimethicone 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, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients: Zinc Oxide/CI77947, Dimethicone

    Soothing balm for baby's tender bottom that helps treat and prevent diaper rash.

    No Such information

    If condition worsens or does not improve within 7 days, consult a doctor.

    For external use only. Avoid contact with eyes

    To use: With each diaper change, cleanse the diaper area and and allow to dry. Apply baby bottom balm liberally, especially when exposure to wet diapers may be prolonged.

    Other ingredients: Water/aqua, petrolatum, Diisostearoyl Polyglyceryl-3 Diisostearate, Ethylhexyl stearate, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Oil, Butyrospermum Parkii (Shea Butter) Fruit, Panthenol, Glycine Soja (Soybean) Oil. Cetyl Dimethicone, Magnesium Sulfate, Beeswax/Cera Alba, Butylene Glycol, DMDM Hydantoin, PEG-4 Laurate, Iodopropynyl Butylcarbamate.



    image of carton back
  • PRINCIPAL DISPLAY PANEL

    Tender Moments

    Baby Bottom Balm

    Crema Suavizante para Rozaduras


    Jafra 

     50 ml 1.7 fl. oz



    image of carton front

  • INGREDIENTS AND APPEARANCE
    TENDER MOMENTS  BABY BOTTOM BALM
    zinc oxide, dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-095
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OAT (UNII: Z6J799EAJK)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-095-011 in 1 BOX06/07/2012
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/07/2012
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-095)
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