Label: SOLAR PROTECTION FORMULA TIZO BODY- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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 September 2, 2010

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients:

    Zinc Oxide 20%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • Provides protection from UVA & UVB rays that may contribute to premature aging of the skin
    • Retains SPF up to 40 minutes of water immersion or perspiring
  • Warnings

    • For external use only
    • Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
    • Do not use if sensitive to ingredients
    • Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
    • For use on children less than 6 months of age, consult a doctor
    • Keep this and all medicines out of the reach of children
    • If swallowed, get medical help or contact a Poison Control Center
  • Directions

    • Apply generously and uniformly to all exposed skin areas before exposure to sunlight
    • Continue to rub in until fading occurs, especially in hair bearing areas
    • Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection
  • Other Information

    • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
    • May stain some fabrics
  • Inactive Ingredients:

    C12-15 Alkyl Benzoate, Caprylhydroxyamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylysilane, Water

    TiZO Body SPF 35 is a sunscreen uniquely formulated to offer sheer, elegant protection with a silky, smooth, matte finish. TiZO Body offers unparalleled aesthetic elegance while providing superb photoprotective performance. Using our proprietary technology, Fallien has formulated multiple particle sizes of micronized zinc oxide into a light, silky texture that dries to a clear, yet matte finish on any complexion. TiZO Body is paraben, oil and fragrance free, and specially formulated without UV absorbing chemicals to offer unsurpassed, irritant free UVA/UVB light protection.

  • SPF is not Enough

    UVA radiation is consistently the same all day and all year long. Everyone requires daily, year round UVA protection. UVA radiation is responsible for deep skin damage that results in most of the changes associated with skin aging, such as wrinkling. In addition, the effects of UVA damage are cumulative. Since the SPF number does not define the level of UVA protection, products that utilize both titanium dioxide and/or zinc oxide, are the best method of assuring full spectrum sun protection from UVA and UVB radiation.

    • Excellent for Sensitive Skin
    • Free of "Chemical Sunscreen Filters"
    • Contains no Parabens
    • Dries Translucent
    • Full Spectrum Protection
    • Fragrance Free

    Manufactured exclusively for
    Fallien, Ltd.
    West Norriton PA 19403
    Made in USA

  • Principal Display Panel – Carton Label

    NDC 58892-218-01

    SOLAR

    PROTECTION

    Formula®

    TIZO®

    BODY

    20% Zinc Oxide Mineral Protection

    Water Resistant

    spf 35

    uva/uvb

    Net Wt 3.5 oz. / 100g

    Principal Display Panel – Carton Label
  • INGREDIENTS AND APPEARANCE
    SOLAR PROTECTION FORMULA TIZO BODY   SUNSCREEN
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-218
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydroxystearic Acid (UNII: 933ANU3H2S)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    .Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)  
    Trolamine (UNII: 9O3K93S3TK)  
    Octyltriethoxysilane (UNII: LDC331P08E)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-218-011 in 1 CARTON
    1100 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2010
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies & Packaging809172885MANUFACTURE, PACK
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS
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