Label: COTZ FACE MOISTURE- zinc oxide cream

  • NDC Code(s): 58892-360-42
  • Packager: Fallien Cosmeceuticals, LTD
  • Category: HUMAN OTC DRUG LABEL

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:

    Zinc Oxide 16%

  • 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 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:

    Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

  • 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 – Carton Label

    CoTZ®
    the HEALTHIER SUNSCREEN®

    Face
    Moisture

    Lightly Tinted

    SPF
    35

    Hydrate & Protect
    MINERAL SUNCREEN

    FACE

    Broad Spectrum SPF 35

    Water Resistant (80 Minutes)

    Net Wt. 1.5 oz/42.5 g

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

    CoTZ®
    the HEALTHIER SUNSCREEN®

    Face
    Moisture

    Lightly Tinted

    SPF
    35

    Hydrate & Protect
    MINERAL SUNCREEN

    FACE

    Broad Spectrum SPF 35

    Water Resistant (80 Minutes)

    Net Wt. 1.5 oz/42.5 g

    Principal Display Panel – Tube Label
  • INGREDIENTS AND APPEARANCE
    COTZ FACE MOISTURE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide160 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone 20 (UNII: H8YMB5QY0D)  
    Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
    Dimethiconol (2000 CST) (UNII: T74O12AN6Y)  
    Brown Iron Oxide (UNII: 1N032N7MFO)  
    Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)  
    PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-360-421 in 1 CARTON02/04/2019
    142.5 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 finalpart35202/04/2019
    Labeler - Fallien Cosmeceuticals, LTD (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-360) , PACK(58892-360)
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