Label: TIZO PHOTOCEUTICAL ENVIRONMENTAL SKIN PROTECTANT- dimethicone gel

  • NDC Code(s): 58892-105-30
  • Packager: Fallien Cosmeceuticals, LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 12, 2021

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  • Active Ingredients:

    Dimethicone 3%

  • Purpose:

    Skin Protectant

  • Uses:

    • Temporarily protects and helps relieve chapped or cracked skin.
    • Helps protect from the drying effects of wind and cold weather.
  • Warnings:

    • For external use only.

    Do not use on:

    • deep puncture wounds
    • animal bites
    • serious burns

    When using this product:

    • Do not get into eyes

    Stop use and ask doctor if:

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach out children.

    If swallowed, get medical help or contact a poison control center right away.

  • Directions:

    • Gently cleanse and dry affected area
    • Apply liberally to affected area as needed
  • Inactive Ingredients:

    Bisabolol, Caprylhydroxamic Acid, Caprylyl Glycol, Ceramide 3, Copper PCA Methylsilanol, Cydohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Isohexadecane, Isononyl Isononanoate, Lauryl PEG/PPG-18/18 Hydrogen Dimethicone, Propyl Gallate, Polysorbate 20, Saccharomyces/ Copper Ferment, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer, Water

  • Principal Display Panel – Carton Label

    ENVIRONMENTAL

    SKIN PROTECTANT

    TIZO®

    PHOTOCEUTICAL®

    Especially effective against
    environmental damage

    Dimethicone 3%

    Copper Peptides

    Bisabolol

    featuring

    SKIN FIRM TECHNOLOGY®

    1 Fl. Oz./29 ml

    Principal Display Panel – Carton Label
  • Principal Display Panel – Bottle Label

    TIZO®

    PHOTOCEUTICAL®

    ENVIRONMENTAL

    SKIN PROTECTANT

    Dimethicone 3%

    Copper Peptides

    Bisabolol

    featuring

    SKIN FIRM TECHNOLOGY®

    1 Fl. Oz./29 ml

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    TIZO PHOTOCEUTICAL ENVIRONMENTAL SKIN PROTECTANT 
    dimethicone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    COPPER PIDOLATE (UNII: 497G7G1SL1)  
    METHYLSILANOL PCA (UNII: 837430510V)  
    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)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-105-301 in 1 CARTON07/23/2019
    129 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/20/2018
    Labeler - Fallien Cosmeceuticals, LTD (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-105) , PACK(58892-105)
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