Label: TIZO EYE RENEWAL SPF 20 (NON-TINTED)- zinc oxide cream

  • NDC Code(s): 58892-113-15
  • Packager: Fallien Cosmeceuticals, LTD
  • 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 20, 2022

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  • Active Ingredients:

    Zinc Oxide 9%

  • Purpose:

    Sunscreen

  • Uses:

    Helps prevents 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 reach of children. If swallowed, get medical help or contact a poison control center right away.

  • Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant product if swimming or sweating.
    • Reapply 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:

    Butylene Glycol, Caffeine, Carbomer, Caprylhydroxamic Acid, Caprylyl Glycol, Corallina Officinalis Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Hydrogen Dimethicone, Isododecane, Isohexadecane, Lauryl PEG/PPG-18/18 Hydrogen Dimethicone,PaImitoyI Tripeptide-1, PaImitoyl Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20, Saccharomy- ces/Selenium Ferment, Sambucus Nigra Flower Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undaria Pinnatifida Extract, Water

  • Other Information:

    • Protect this product from excessive heat and direct sun.
  • Principal Display Panel - 100 g Carton Label

    MINERAL
    PROTECTION

    TIZO®

    EYE RENEWAL

    NON-TINTED
    SPF 20

    Firming Eye Repair

    Mineral Sunscreen

    Gentle Zinc Oxide

    Peptides

    Botanical Blend

    Broad Spectrum SPF 20

    Net Wt. 0.5 oz/15 g

    Principal Display Panel - 100 g Carton Label
  • INGREDIENTS AND APPEARANCE
    TIZO EYE RENEWAL SPF 20 (NON-TINTED) 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide90 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Caffeine (UNII: 3G6A5W338E)  
    Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Corallina Officinalis (UNII: 4004498D06)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
    Dimethiconol (2000 CST) (UNII: T74O12AN6Y)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)  
    Isododecane (UNII: A8289P68Y2)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)  
    Palmitoyl Tripeptide-1 (UNII: RV743D216M)  
    Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)  
    PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Saccharomyces Cerevisiae (UNII: 978D8U419H)  
    Sambucus Nigra Flower (UNII: 07V4DX094T)  
    Silanetriol (UNII: E52D0J3TS5)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Undaria Pinnatifida (UNII: ICV1OK7M1S)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-113-151 in 1 CARTON09/01/2020
    115 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2020
    Labeler - Fallien Cosmeceuticals, LTD (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-113)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-113) , PACK(58892-113)
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