Label: TIZO PHOTOCEUTICAL AM REPLENISH - TINTED- zinc oxide cream

  • NDC Code(s): 58892-101-50
  • Packager: Fallien Cosmeceuticals, LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2024

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  • Active Ingredients:

    Zinc Oxide 16%

  • 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:

    Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer

  • Other Information:

    • Protect this product from excessive heat and direct sun.
    • May stain some fabrics.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Principal Display Panel – Carton Label

    AM
    REPLENISH

    Lightly Tinted
    SPF 40

    TIZO®

    PHOTOCEUTICAL®

    Enhances, protects &
    neutralizes free radicals

    Mineral Sunscreen

    Ceramides

    Antioxidants C & E

    featuring

    SKIN FIRM TECHNOLOGY®

    Broad Spectrum SPF 40

    Net Wt. 1.75 oz/50 g

    Principal Display Panel – Carton Label
  • Principal Display Panel – Tube Label

    TIZO®

    PHOTOCEUTICAL

    AM
    REPLENISH

    Lightly Tinted

    Mineral Sunscreen

    Ceramides

    Antioxidants C & E

    featuring

    SKIN FIRM TECHNOLOGY®

    SPF 40
    Broad Spectrum

    1.75 Fl. Oz/50 mL

    Principal Display Panel – Tube Label
  • INGREDIENTS AND APPEARANCE
    TIZO PHOTOCEUTICAL AM REPLENISH - TINTED 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE160 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE 20 (UNII: H8YMB5QY0D)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-101-501 in 1 CARTON07/23/2019
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/13/2015
    Labeler - Fallien Cosmeceuticals, LTD (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372analysis(58892-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000manufacture(58892-101) , pack(58892-101)
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