Label: PROCEUTICALS PRIVATE LABEL BY TIZO MINERAL LIP SUNSCREEN- titanium dioxide, zinc oxide stick

  • NDC Code(s): 58892-212-45
  • Packager: Fallien Cosmeceuticals, LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 16, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:
    Titanium Dioxide 4%
    Zinc Oxide 5.5%

  • PURPOSE

    PURPOSE:Sunscreen

  • INDICATIONS & USAGE

    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
    • Children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate. Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Disostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oi

  • WARNINGS

    WARNINGS:For external use only. Do not use on damaged or broken skin. Stop
    use and ask a doctor if rash occurs. When using this product, keep out of eyes.
    Rinse with water to remove. Keep out of the reach of children. Get medical help
    or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of
    children.

  • DOSAGE & ADMINISTRATION

    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.

    Apply liberally 15 minutes before sun exposure.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 53 g Bottle Label

    Proceuticals

    PRIVATE LABEL by TiZO

    non-tinted
    mineral sunscreen

    broad spectrum spf 40
    water resistant (80 minutes)

    net wt. 1.8 oz / 53 g

    Graphic-Untitled

    58892-212-45 mineral lip sunscreen Reference

  • INGREDIENTS AND APPEARANCE
    PROCEUTICALS PRIVATE LABEL BY TIZO MINERAL LIP SUNSCREEN 
    titanium dioxide, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE55 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T)  
    KIWI FRUIT OIL (UNII: 66086CWP3Q)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)  
    CERESIN (UNII: Q1LS2UJO3A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-212-454.5 g in 1 TUBE; Type 0: Not a Combination Product07/16/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/16/2024
    Labeler - Fallien Cosmeceuticals, LTD (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372analysis(58892-212)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000pack(58892-212) , manufacture(58892-212)