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

Drug Label Information

Updated November 14, 2024

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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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • 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 DrugM02006/20/2018
    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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