Label: COTZ SENSITIVE- zinc oxide cream

  • NDC Code(s): 58892-410-01
  • 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 15, 2021

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  • DRUG FACTS

  • Active Ingredients:

    Zinc Oxide 20%

  • Purpose:

    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 40 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:

    C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

  • Other Information:

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

    Manufactured Exclusively For:

    CoTZ® Skincare
    Norristown, PA 19403

    www.cotzskincare.com

  • Principal Display Panel – CoTZ Sensitive Tube Label

    CoTZ®

    the HEALTHIER
    SUNSCREEN®

    Sensitive

    Non-Tinted

    SPF
    40

    Gentle Zinc Oxide

    MINERAL SUNSCREEN

    FACE & BODY

    Broad Spectrum SPF 40

    Water Resistant (40 minutes)

    Net Wt. 3.5 oz/100 g

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

    CoTZ®

    the HEALTHIER
    SUNSCREEN®

    Sensitive

    Non-Tinted

    SPF
    40

    Gentle Zinc Oxide

    MINERAL SUNSCREEN

    FACE & BODY

    Broad Spectrum SPF 40

    Water Resistant (40 minutes)

    Net Wt. 3.5 oz/100 g

    Principal Display Panel – CoTZ Sensitive Carton Label
  • INGREDIENTS AND APPEARANCE
    COTZ SENSITIVE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-410-011 in 1 CARTON11/26/2018
    1100 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 finalpart35202/15/2015
    Labeler - Fallien Cosmeceuticals, LTD (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-410)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-410) , PACK(58892-410)
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