COTZ KIDS PURE BOTANICALS- titanium dioxide, zinc oxide cream

CoTZ Kids Pure Botanicals by

Drug Labeling and Warnings

CoTZ Kids Pure Botanicals by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD, Custom Analytics LLC, Fragrance Manufacturing Inc. (FMI). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • Inactive Ingredients:

    Butyrospermum Parkii (Shea) Butter (Shea Tree Extract), C12-15 Alkyl Benzoate (from Cranberries & Coconut), Camellia Sinensis (Green Tea) Leaf Extract, Capric/Caprylic Triglyceride (From Coconut), Glyceryl Caprylate (From Coconut), Glyceryl Undecylenate (From Castor Bean & Coconut), Melissa Officinalis (Balm Mint) Extract (Natural Herb), Olive Oil Polyglyceryl-6 Esters (From Glycerin & Olive Oil), Polyglyceryl-6 Pentaoleate (From Glycerin & Olive Oil), Polyhydroxystearic Acid (From Castor Plant), Propanediol (From Corn), Rosemarinus Officinalis (Rosemary) Extract (Natural Herb), Salvia Officinalis (Sage) Leaf Extract (Natural Herb), Sclerocarya Birrea (Marula) Seed Oil (Tree Fruit Extract), Simmondsia Chinensis (Jojoba) Esters (From Natural Plant), Sodium Chloride (Natural Mineral), Sodium Stearoyl Glutamate (From Coconut & Amino Acid), Tetradecane (Derived from Vegetable Oil), Tetrahexyldecyl Ascorbate (From Mixed Citrus and Palm Oil), Tocopherol (From Mixed Fruit & Seed Extracts), Tocopheryl Acetate (From Mixed Fruit & Seed Extracts), Water

  • Other Information:

    • Protect this product from excessive heat and direct sun.
    • May stain some fabrics.

    Manufactured Exclusively For:
    CōTZ® Skincare
    Norristown, PA 19403

    www.cotzskincare.com

  • Principal Display Panel – Carton Label

    CoTZ®
    the HEALTHIER
    SUNCREEN®

    Kids
    Pure Botanicals

    Non-Tinted

    SPF
    45

    Plant Based
    Mineral Sunscreen

    For 6+ Months

    Broad Spectrum SPF 45

    Water Resistant (80 Minutes)

    Net Wt. 4 oz/113 g

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

    CoTZ®
    the HEALTHIER
    SUNCREEN®

    Kids
    Pure Botanicals

    Non-Tinted

    SPF
    45

    Plant Based
    Mineral Sunscreen

    For 6+ Months

    Broad Spectrum SPF 45

    Water Resistant (80 Minutes)

    Net Wt. 4 oz/113 g

    Principal Display Panel – Tube Label
  • INGREDIENTS AND APPEARANCE
    COTZ KIDS PURE BOTANICALS 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58892-603
    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: 58892-603-041 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(58892-603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-603) , PACK(58892-603)

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