Label: LIPCOTZ- titanium dioxide, zinc oxide lipstick

  • 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 September 9, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Titanium Dioxide 4.0%

    Zinc Oxide 5.5%

  • Purpose

    Sunscreen

    Sunscreen

  • Uses:

    Helps prevent sunburn; higher SPF gives more sunburn protection for skin that sunburns easily

  • Warnings:

    For External Use Only. Stop use and consult a physician if rash or irritation develops. Avoid contact with eyes.

  • Keep out of reach of children:

    If swallowed, get medical help or contact a Poison Control Center.

  • Directions:

    Apply generously to lips prior to sun exposure. Reapply often and after water activity, excessive perspiration or towel drying. Children under 6 years old, consult a physician.

  • Inactive Ingredients:

    Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxides, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxy Stearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Offinale (Ginger) Root Oil

  • Principal Display Panel – Carton Label

    NDC 58892-125-87

    SPF 45

    LIPCŌTZ

    Contains Only Titanium & Zinc™

    SPF 45

    Contains Only Titanium & Zinc™

    Ultra High Sun Protection no chemical sunscreen filters

    Net Wt. .14 Oz./ 4.5 g

    For Information Call:

    800-332-5536

    Manufactured for: Fallene, Ltd

    West Norriton, PA

    Principal Display Panel – Carton Label
  • INGREDIENTS AND APPEARANCE
    LIPCOTZ   LIP BALM/SUNSCREEN
    titanium dioxide, zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide55 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aluminum Oxide (UNII: LMI26O6933)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Aluminum Stearate (UNII: U6XF9NP8HM)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Cetearyl Isononanoate (UNII: P5O01U99NI)  
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Kiwi Fruit (UNII: 71ES77LGJC)  
    Lime (Citrus) (UNII: 8CZS546954)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Hexyldecanol (UNII: 151Z7P1317)  
    Hexyldecyl Laurate (UNII: 0V595C1P6M)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    .ALPHA.-Tocopherol Acetate, D- (UNII: A7E6112E4N)  
    Ginger Oil (UNII: SAS9Z1SVUK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-125-871 in 1 CARTON
    14.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2005
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies & Packaging809172885MANUFACTURE, PACK
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS
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