Label: COTZ PEDIATRIC SPF 40 SUNSCREEN - zinc oxide lotion

  • NDC Code(s): 58892-518-01
  • Packager: Fallien Cosmeceuticals, LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

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  • Active Ingredients:

    Zinc Oxide 20 %

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  • Purpose

    Sunscreen

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  • 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.

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  • 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.

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  • Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Reapply:
      -
      After 40 minutes of swimming or sweating
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      Immediately after towel drying
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      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.
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      Wear long-sleeved shirts, pants, hats, and sunglasses
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  • Inactive Ingredients:

    C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Getyl PEG/PPG 10/1 Dimethicone, Cyelohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dlmethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Methicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydraxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Triethanolamine, Triethoxycaprylylsilane, Water

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  • Other Information:

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics
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  • Principal Display Panel – SPF 40 100g Carton Label

    PEDIATRICIAN RECOMMENDED

    CoTZ®

    PEDIATRIC

    The Healthier SunscreenTM Gentle Mineral ComplexTM #1 Rated UV Protection*
    Will Not Irritate or Sting

    Helps Prevent Heat Build-Up in Skin
    which can Damage the Dermis

    100% Free of:

    Chemical Sunscreens & Fragrances

    SPF 40
    Broad
    Spectrum
    UVA-UVB

    Easy to Apply
    Water Resistant
    (40 minutes)

    Net Wt. 3.5 oz/100 g

    Principal Display Panel – SPF 40 100g Carton Label
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  • INGREDIENTS AND APPEARANCE
    COTZ PEDIATRIC SPF 40   SUNSCREEN
    zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58892-518
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Oxide (Zinc Oxide) Zinc Oxide 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Alkyl (C12-15) Benzoate  
    Caprylhydroxamic Acid  
    Caprylyl Glycol  
    Cetyl PEG/PPG-10/1 Dimethicone (HLB 5)  
    Cyclomethicone 6  
    Cyclomethicone 5  
    Dimethicone 100  
    Dimethicone/Diene Dimethicone Crosspolymer  
    Edetate Disodium  
    Methicone (20 cst)  
    Microcrystalline Wax  
    PEG-10 Dimethicone (600 cst)  
    PEG-30 Dipolyhydroxystearate  
    Polyglyceryl-4 Isostearate  
    Polyhydroxystearic Acid (2300 MW)  
    Polysorbate 20  
    Sodium Chloride  
    Stearyl Dimethicone (400 MPA.S AT 50C)  
    Tetrahexyldecyl Ascorbate  
    .Alpha.-Tocopherol Acetate  
    Trolamine  
    Triethoxycaprylylsilane  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58892-518-01 1 in 1 CARTON
    1 100 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 09/07/2012
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    Name Address ID/FEI Business Operations
    Custom Analytics LLC 144949372 ANALYSIS(58892-518)
    Establishment
    Name Address ID/FEI Business Operations
    Process Technologies & Packaging 809172885 MANUFACTURE(58892-518)
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