Label: TIZO SHEER BOTANICALS NON-TINTED- titanium dioxide, zinc oxide cream

  • NDC Code(s): 58892-108-04
  • Packager: Fallien Cosmeceuticals, LTD
  • 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 January 12, 2021

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  • Active Ingredients:

    Titanium Dioxide 3.0%

    Zinc Oxide 10%

  • Purpose:

    Sunscreen

    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. 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.

  • 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
    • 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 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Inactive Ingredients:

    Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Camellia Olefira (Green Tea) Leaf Extract, Capric/Caprylic Triglyceride, Glyceryl Caprylate, Glyceryl Undecylenate, Melissa Officinalis (Balm Mint) Extract, Olive Oil Polyglyceryl-6 Esters, Polyglyceryl-6 Pentaoleate, Polyhydroxystearic Acid, Propanediol, Rosemarinus Officinalis (Rosemary) Extract, Salvia Officinalis (Sage) Leaf Extract, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Esters, Sodium Chloride, Sodium Stearoyl Glutamate, Tetradecane, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Water

  • Other Information:

    • Protect this product from excessive heat and direct sun.
    • Cleanse thoroughly at nighttime.
  • Principal Display Panel – Carton Label

    MINERAL
    PROTECTION

    TIZO®

    SHEER BOTANICALS

    NON-TINTED
    SPF 45

    Plant Based
    Mineral Sunscreen

    For Body & Face

    Titanium & Zinc Oxides

    Antioxidants C & E

    Broad Spectrum SPF 45

    Water Resistant (80 minutes)

    Net Wt. 4 oz/113 g

    Principal Display Panel – Carton Label
  • Principal Display Panel – Tube Label

    MINERAL
    PROTECTION

    TIZO®

    SHEER BOTANICALS

    NON-TINTED
    SPF 45

    Plant Based
    Mineral Sunscreen

    For Body & Face

    Titanium & Zinc Oxides

    Antioxidants C & E

    Broad Spectrum SPF 45

    Water Resistant (80 minutes)

    Net Wt. 4 oz/113 g

    Principal Display Panel – Tube Label
  • INGREDIENTS AND APPEARANCE
    TIZO SHEER BOTANICALS NON-TINTED 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide30 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    MELISSA OFFICINALIS (UNII: YF70189L0N)  
    POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SAGE (UNII: 065C5D077J)  
    SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)  
    SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    1-TETRADECENE (UNII: FW23481S7S)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-108-041 in 1 CARTON04/15/2019
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/15/2019
    Labeler - Fallien Cosmeceuticals, LTD (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-108)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-108) , PACK(58892-108)
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