Label: LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 MEDIUM- octinoxate and zinc oxide lotion

  • 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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  • Active ingredients

    Octinoxate 3% and Zinc Oxide 3%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    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 use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor.
  • Inactive Ingrediets:

    Aloe Barbadensis Leaf Juice, Bentonite, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cholecalciferol, Cyclohexasiloxane, Cyclopentasiloxane, Disodium EDTA, DMDM Hydantoin, Hexyl Laurate, Hydrogenated Castor Oil, Iron Oxides, Isocetyl Stearate, Melanin, Octyl Stearate, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sodium Chloride, Titanium Dioxide, Tocopheryl Acetate, Water

  • Other information

    • protect this product from excessive heat and direct sun

  • Questions or comments? Call toll free 1-866-977-1412

  • PRINCIPAL DISPLAY PANEL - 30mL  Bottle Label

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

    bb

    cream

    Hydrating Anti-Oxidant

    Beauty Balm


    Broad Spectrum

    SPF 30


    medium


    Sunscreen Lotion

    Water Resistant (80 Minutes)


    LifeCell

    South Beach Skincare


    1 FL OZ (30mL)

  • INGREDIENTS AND APPEARANCE
    LIFECELL  BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 MEDIUM
    octinoxate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0183
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE29.4 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION29.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CARAMEL (UNII: T9D99G2B1R)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    MELAMINE (UNII: N3GP2YSD88)  
    OCTYL STEARATE (UNII: 772Y4UFC8B)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0183-330 mL in 1 BOTTLE; Type 0: Not a Combination Product08/13/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/13/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0183) , pack(58443-0183) , manufacture(58443-0183) , analysis(58443-0183)
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