Label: SOLAR PROTECTION FORMULA TIZO SPF 35 SUNSCREEN- zinc oxide lotion

  • 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:

    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 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 10:00 a.m.-2 p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Other Information:

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics
  • Inactive Ingredients:

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

    Manufactured exclusively for
    Fallien, Ltd.
    West Norriton PA 19403
    Made in USA

  • Principal Display Panel – SPF 35 100g Carton Label

    NDC 58892-318-01

    SOLAR

    PROTECTION

    FORMULA®

    TiZO®

    For Ultra

    Sensitive Skin

    20% Zinc Oxide

    Pure Mineral Protection

    SPF 35

    Broad Spectrum

    Water Resistant

    (40 minutes)

    Net Wt. 3.5 Oz./ 100g

    Principal Display Panel – SPF 35 100g Carton Label
  • INGREDIENTS AND APPEARANCE
    SOLAR PROTECTION FORMULA TIZO SPF 35   SUNSCREEN
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-318
    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/Diene Dimethicone Crosspolymer (UNII: RSA9I561OK)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Methicone (20 cst) (UNII: 6777U11MKT)  
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    PEG-10 Dimethicone (600 cst) (UNII: 8PR7V1SVM0)  
    PEG-30 Dipolyhydroxystearate (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:58892-318-011 in 1 CARTON
    1100 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/02/2012
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-318)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies & Packaging809172885MANUFACTURE(58892-318)
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