Label: COTZ PURE SPF 30 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 December 18, 2012

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients:

    Titanium Dioxide 4.1%

    Zinc Oxide 8.4%

  • 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 40 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:

    Brassica Campestris/Aleurites Fordii Oil Copolymer1 (from rapeseed and aleurites oils), Butyrospermum Parkii (Shea) Butter1 (shea tree extract), Camellia Oleifera Leaf Extract1 (Japanese green tea), Capric/Caprylic Triglyceride1,2,3(from coconut), Cellulose Gum1(from plant), Cetearyl Alcohol1,2,3(from coconut/ palm), Cetearyl Glucoside1,2,3(from coconut/palm and glucose sugar), Citric Acid (from citrus fruit), Glyceryl Caprylate1,2(from coconut), Glyceryl Undecylenate1,2(from castor bean and coconut glycerin), Iron Oxide1 (CI 77491) (natural mineral), Melissa Officinalis (Balm Mint) Extract1 (natural herb), Microcrystalline Cellulose1 (from wood pulp), Polyhydroxystearic Acid2(from castor plant), Rosmarinus Officinalis (Rosemary) Extract1 (natural herb), Salvia Officinalis (Sage) Leaf Extract1 (natural herb), Simmondsia Chinensis (Jojoba) Esters1,2(from natural plant) Sodium Stearoyl Glutamate1,2,3(from coconut and amino acid), Sorbitan Oleate Decylglucoside Crosspolymer4(from sugar and plant derived oleic acid), Xanthan Gum1(from plant sugar), Water

  • Other Information:

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

    * All ingredients approved by one or more of these leading organizations: 1. Natural Products Association, 2. EcoCert, 3 NSF International, 4. Green Star Rated

  • Principal Display Panel – SPF 30 85g Carton Label

    DERMATOLOGIST RECOMMENDED

    CoTZ®

    PURE

    The Healthier Sunscreen
    0%
    Synthetic Ingredients
    Preservatives
    Chemical Sunscreens

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

    Broad
    Spectrum
    SPF 30

    Silky Soft & Gentle
    Water Resistant
    (40 minutes)

    Net Wt. 3.5 oz/85.0 g

    Principal Display Panel – SPF 30 85g Carton Label
  • INGREDIENTS AND APPEARANCE
    COTZ PURE SPF 30   SUNSCREEN
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide41 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide84 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Shea Butter (UNII: K49155WL9Y)  
    Camellia Oleifera Leaf (UNII: 5077EL0C60)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Glyceryl Caprylate (UNII: TM2TZD4G4A)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Melissa Officinalis (UNII: YF70189L0N)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
    Rosemary (UNII: IJ67X351P9)  
    Sage (UNII: 065C5D077J)  
    Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-600-011 in 1 CARTON
    185 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/14/2012
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies & Packaging809172885MANUFACTURE(58892-600) , PACK(58892-600)
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