Label: TIZO SHEERFOAM - TINTED- titanium dioxide, zinc oxide aerosol, foam

  • NDC Code(s): 58892-230-01
  • 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 December 29, 2022

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  • Active Ingredients:

    Titanium Dioxide 3%

    Zinc Oxide 10%

  • Purpose

    Sunscreen

    Sunscreen

  • Uses:

    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.

  • 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.

  • Directions:

    Shake well before using. Use caution during first application. 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 ingredients:

    Bismuth Oxychloride, 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, Iron Oxides, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, Mica. Macrocrystalline Cellulose, Octyldodecyl Erucate, Octyldodecyl Neopentanoate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid. Polysorbate 80, Trans-1,3,3,3- Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water

  • Other Information:

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics
    • Store between 68° to 104° F (20° to 40°C)
    • Do not store at temperatures above 120° F
  • Principal Display Panel – 1 Can Carton Label

    TiZO®

    SHEERFOAM™

    Tinted

    SPF
    30

    MINERAL SUNSCREEN
    FOR BODY & FACE

    Titanium & Zinc Oxides

    Weightless

    Spreads Easily

    Broad Spectrum SPF 30

    Water Resistant (40 minutes)

    Net Wt. 3.5 Oz/100 g

    Principal Display Panel – 1 Can Carton Label
  • Principal Display Panel – 100g Can Label

    MINERAL
    PROTECTION

    TIZO®
    SHEERFOAM™

    TINTED
    SPF 30

    Mineral Sunscreen
    For Body & Face

    Titanium & Zinc Oxides

    Weightless

    Spreads Easily

    Broad Spectrum SPF 30

    Water Resistant (40 minutes)

    Net Wt. 3.5 oz/100 g

    Principal Display Panel – 100g Can Label
  • INGREDIENTS AND APPEARANCE
    TIZO SHEERFOAM - TINTED 
    titanium dioxide, zinc oxide aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-230
    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
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISODODECANE (UNII: A8289P68Y2)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    Mica (UNII: V8A1AW0880)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    OCTYLDODECYL ERUCATE (UNII: D4N66T98C2)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-230-011 in 1 CARTON12/01/2022
    1100 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/20/2012
    Labeler - Fallien Cosmeceuticals, LTD (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-230)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tri-Pac Inc020844956MANUFACTURE(58892-230)
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