Label: COTZ SPORT NON-TINTED- titanium dioxide, zinc oxide cream

  • NDC Code(s): 58892-604-04
  • 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 June 4, 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 Polson 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 two 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 (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 Com), Rosemarinus Officinalis (Rosemary) Extract (Natural Herb), Salvia Officinalis (Sage) Leaf Extract (Natural Herb), Sclerocarya Birrea (Marula) Seed Oil (Tree Fruit Extract), Simmondsia Chinensls (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.

    Manufactured Exclusively For:
    CoTZ® Skincare
    Norristown, PA 19403

    www.cotzskincare.com

  • Principal Display Panel - 113 g Carton Label

    CoTZ®

    the HEALTHIER
    SUNSCREEN®

    Sport

    Non-Tinted

    SPF
    45

    Active Performance

    MINERAL SUNSCREEN

    FACE & BODY

    Broad Sprectrum SPF 45

    Water Resistant (80 minutes)

    Net Wt. 4 oz/113 g

    Principal Display Panel - 113 g Carton Label
  • INGREDIENTS AND APPEARANCE
    COTZ SPORT NON-TINTED 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-604
    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:58892-604-041 in 1 CARTON01/01/2020
    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 finalpart35201/01/2020
    Labeler - Fallien Cosmeceuticals, LTD (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-604)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-604) , PACK(58892-604)
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