Label: LIFECELL BROAD SPECTRUM SPF 30 MINERAL- octinoxate, zinc oxide cream

  • NDC Code(s): 58443-0426-3
  • Packager: Prime Enterprises Inc.
  • 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 September 17, 2021

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  • Active ingredients

    Octinoxate 3 %

    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 doctor if rash occurs

    Keep out of reach of children. If product

    is swallowed get medical help or contact

    a Posion Cotrol center right away

    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 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-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive ingredients:

    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, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Isocetyl Stearate, Melanin, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sodium Chloride, Titanium Dioxide, Tocopheryl Acetate, Triethoxycaprylylsilane, Water, Iron Oxides

  • Other information

    • protect this product from excessive heat and direct sun
  • Questions or comments?

    Call toll free 1-866-978-5848

  • LifeCell Hydrating Antioxidant Medium BB Cream Broad Spectrum SPF 30 - 50 mL

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    LIFECELL  BROAD SPECTRUM SPF 30 MINERAL
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0426
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30.03 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30.03 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    BENTONITE (UNII: A3N5ZCN45C)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CARAMEL (UNII: T9D99G2B1R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    D&C BLACK NO. 2 (UNII: 4XYU5U00C4)  
    Product Characteristics
    Colorbrown (Nude) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0426-350 mL in 1 BOTTLE; Type 0: Not a Combination Product10/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/23/2015
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0426) , manufacture(58443-0426) , label(58443-0426) , analysis(58443-0426)
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