Label: PROCEUTICALS PRIVATE LABEL BY TIZO DAILY DEFENSE TINTED MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream

  • NDC Code(s): 58892-258-50
  • Packager: Fallien Cosmeceuticals, LTD
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 8, 2024

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:
    Titanium Dioxide 10%
    Zinc Oxide 3%

  • PURPOSE

    PURPOSE:Sunscreen

  • INDICATIONS & USAGE

    DIRECTIONS:
    • Apply liberally 15 minutes before sun exposure.
    • Reapply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • Children under 6 months: Ask a doctor
    • 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 value of 15 or
    higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 am-2 pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:
    Bismuth Oxychloride, Capric/Caprylic Triglyceride,
    Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20,
    Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium
    EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides,
    Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint)
    Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate,
    PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl
    Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine,
    Triethoxycaprylylsilane, Water

  • OTHER SAFETY INFORMATION

    OTHER INFORMATION:
    • Protect this product from excessive heat and direct sun
    • May stain some fabrics

  • 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. If swallowed, 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

    daily defense tinted
    mineral sunscreen

    broad spectrum spf 50
    water resistant (40 minutes)

    net wt. 1.8 oz / 53 g

    Graphic-Untitled

    58892-258-50 proceuticals reference

  • INGREDIENTS AND APPEARANCE
    PROCEUTICALS PRIVATE LABEL BY TIZO DAILY DEFENSE TINTED MINERAL SUNSCREEN 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-258
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYL HYDROXYSTEARATE BENZOATE (UNII: 3W8F25684B)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ISODODECANE (UNII: A8289P68Y2)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-258-5053 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/08/2024
    Labeler - Fallien Cosmeceuticals, LTD (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372analysis(58892-258)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000pack(58892-258) , manufacture(58892-258)
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