Label: COTZ FACE (FOR LIGHTER SKIN TONES) SPF 40 SUNSCREEN- titanium dioxide, zinc oxide cream

  • 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 3, 2013

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients:

    Titanium Dioxide 8%

    Zinc Oxide 3.8%

  • 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:

    Alumina, Cyclohexasiloxane, Cydopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone

  • Other Information:

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics
  • Principal Display Panel – 1.5 oz Carton Label

    DERMATOLOGIST RECOMMENDED

    CoTZ®

    FACE

    The Healthier SunscreenTM

    Silky Soft
    Sheer Matte Finish

    Balanced Mineral ComplexTM Helps Prevent
    Heat Build-Up in Skin, which can
    Damage the Dermis

    100% Free of:

    Preservatives, Chemical Sunscreens, Oils

    SPF 40

    Broad

    Spectrum

    UVA-UVB

    For Lighter
    Skin Tones

    Water Resistant
    (80 minutes)

    Net Wt. 1.5 oz/42.5 g

    Principal Display Panel – 1.5 oz Carton Label
  • INGREDIENTS AND APPEARANCE
    COTZ FACE (FOR LIGHTER SKIN TONES) SPF 40   SUNSCREEN
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-347
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide80 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aluminum Oxide (UNII: LMI26O6933)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone 20 (UNII: H8YMB5QY0D)  
    Dimethicone/Diene Dimethicone Crosspolymer (UNII: RSA9I561OK)  
    Dimethiconol (100000 cst) (UNII: OSA9UP217S)  
    Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)  
    Methicone (20 cst) (UNII: 6777U11MKT)  
    PEG-10 Dimethicone (600 cst) (UNII: 8PR7V1SVM0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-347-451 in 1 CARTON
    142.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/19/2012
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-347)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies & Packaging809172885MANUFACTURE(58892-347)
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