Label: PROCEUTICALS PRIVATE LABEL BY TIZO NON-TINTED FOAMING MINERAL SUNSCREEN- titanium dioxide, zinc oxide aerosol, foam

  • NDC Code(s): 58892-211-01
  • Packager: Fallien Cosmeceuticals, Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 9, 2024

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Titanium Dioxide 3%

    Zinc Oxide 10%

  • PURPOSE

    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 aging
    caused by the sun.

  • INDICATIONS & USAGE

    DIRECTIONS:
    • Shake well before using.
    • Press nozzle carefully during first use
    • 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 am -2 pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl
    Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium
    EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Isododecane, Isohexadecane,
    Methyl Methacrylate Crosspolymer, Microcrystalline Cellulose, Octyldodecyl
    Erucate, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate
    80, Trans-1,3,3,3-Tetrafluoropropene, Tricontanyl PVP, Triethoxycaprylylsilane,
    Water

  • OTHER SAFETY INFORMATION

    OTHER INFORMATION:
    • Protect this product from excessive heat and direct sun.
    • Store between 68° to 104° F (20° to 40° C).
    • Do not store at temperatures above 120° F.

  • WARNINGS

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • DOSAGE & ADMINISTRATION

    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.

    Apply liberally 15 minutes befor sun exposure.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 100g Can Label

    PROCEUTICALS

    PRIVATE LABEL by TiZO

    non-tinted foaming

    mineral sunscreen

    broad spectrum spf 30

    water resistant (40 minutes)

    net wt. 3.5 oz/ 100 g

    Graphic-Untitled

    NT Foam proceuticals 58892-211-01 Reference

  • INGREDIENTS AND APPEARANCE
    PROCEUTICALS PRIVATE LABEL BY TIZO NON-TINTED FOAMING MINERAL SUNSCREEN 
    titanium dioxide, zinc oxide aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ISODODECANE (UNII: A8289P68Y2)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    OCTYLDODECYL ERUCATE (UNII: D4N66T98C2)  
    1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-211-01100 g in 1 CAN; Type 0: Not a Combination Product08/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/09/2024
    Labeler - Fallien Cosmeceuticals, Ltd (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tri-Pac Inc020844956manufacture(58892-211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372analysis(58892-211)
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