Home > Drugs A-Z > FaceCoTZ

FaceCoTZ (Fallien Cosmeceuticals, LTD.)

Available Formats

Dosage Form Package Information Links
CREAM 1 TUBE in 1 CARTON (58892-346-45) > 44.4 mL in 1 TUBE Label Information

Complete FaceCoTZ Information

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS


  • Active Ingredient

    Titanium Dioxide 8%

    Zinc Oxide 3.8%


  • Purpose

    Sunscreen

    Sunscreen


  • Uses:

    Helps to prevent and reduce the damaging effects of the sun's Ultraviolet light, including wrinkles and reactions associated with sun damage.


  • Warnings:

    For external use only. Avoid contact with eyes. In case of contact, flush eyes thoroughly. Do not use if sensitive to ingredients. If irritation occurs, discontinue use. If irritation persists, see doctor. Keep this and all mediciations out of reach of children.

    Directions:

    Apply before exposure to sunlight. Apply uniformly and completely to all exposed skin areas. Reapply every 2-3 hours and after washing, swimming, sweating, or towel drying for maximum protection.

    Other Information: May stain some fabrics


  • Inactive Ingredients:

    Alumina, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolyner, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone

    FACECÅŒTZ is a sunscreen uniquely formulated to offer sheer, elegant protection with a silky, smooth, matte finish. FACECÅŒTZ offers unparalleled aesthetic elegance while providing superb photoprotective performance. Using our proprietary technology, Fallien has formulated multiple particle sizes of micronized titanium dioxide and zinc oxide into a light, silky texture that dries to a clear, yet matte finish on any complexion. FACECÅŒTZ 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 reasonsible 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 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

    Made in U.S.A.

    Patented

    Manufactured exclusively for
    Fallene Ltd.,
    West Norriton, PA
    Made in USA PATENTED


  • Principal Display Panel – Carton Label

    NDC 58892-346-45

    Dermatologist

    Recommended for Sensitive Skin

    FACE

    CÅŒTZ

    Contains Only Titanium & ZincTM

    VERY WATER-RESISTANT SUN PROTECTION

    UVA-UVB

    SPF40

    1.5 FL. OZ./44.4 ML

    Principal Display Panel – Carton Label

  • INGREDIENTS AND APPEARANCE
    FACECOTZ   (SUNSCREEN)
    titanium dioxide, zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-346
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 85.4 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 40.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Aluminum Oxide (UNII: LMI26O6933)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58892-346-45 1 in 1 CARTON
    1 44.4 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 03/01/2009
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    Name Address ID/FEI Business Operations
    Process Technologies & Packaging 809172885 MANUFACTURE, PACK
    Establishment
    Name Address ID/FEI Business Operations
    Custom Analytics LLC 144949372 ANALYSIS