Label: LIFECELL BROAD SPECTRUM SPF 30 BB CREAM- octinoxate and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 17, 2020

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  • SPL UNCLASSIFIED SECTION

    DARK

  • Uses

    LifeCell BB cream provides all-day hydration, SPF 30 protection and enough coverage to reduce the appearance of imperfections.

  • Directions

    Apply liberally 20 minutes before sun exposure.

  • Active Ingredients

    Octinoxate 3%

    Zinc Oxide 3%

  • PURPOSE

    Sunscreen

  • OTHER SAFETY INFORMATION

    Hypoallergenic

    Dermatologist Tested

  • Lifecell BB Cream Broad Spectrum SPF 30

    Principle Display Panel

  • INGREDIENTS AND APPEARANCE
    LIFECELL  BROAD SPECTRUM SPF 30 BB CREAM
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE29.01 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE29.01 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CARAMEL (UNII: T9D99G2B1R)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OCTYL STEARATE (UNII: 772Y4UFC8B)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0191-350 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2013
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0191) , manufacture(58443-0191) , label(58443-0191)
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