WET N WILD FERGIE BB CREAM SPF 15 (TITANIUM DIOXIDE) CREAM [MARKWINS BEAUTY PRODUCTS INC.]

WET N WILD FERGIE BB CREAM SPF 15 (TITANIUM DIOXIDE) CREAM [MARKWINS BEAUTY PRODUCTS INC.]
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NDC 12027-105-11
Set ID 41bbc937-9af5-4172-87b4-a8bb753facba
Category HUMAN OTC DRUG LABEL
Packager Markwins Beauty Products Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient

    Titanium Dioxide 3.8%

  • INDICATIONS & USAGE

    Use
    Helps prevent sunburn

    Directions
    Apply liberally 15 minutes before sun exposure
    Reapply at least every 2 hours
    Use a water resistant sunscreen if swimming or sweating
    Children under 6 months: Ask a doctor

  • WARNINGS

    Warnings
    Skin Cancer/Skin Aging Alert:
      Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
    For external use only
    Do not use on
    damaged or broken skin.
    When using this product keep out of eyes.  Rinse with water to remove.
    Stop use and ask a doctor if rash occurs.
    Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water/Eau, Cyclopentasiloxane, Butylene Glycol, Caprylic/Capric Triglyceride, Triethylhexanoin, Cyclohexasiloxane, Alcohol Denat., Cetyl PEG/PPG-10/1 Dimethicone, Squalane, Polyglyceryl-4 Isostearate, Disteardimonium Hectorite, PEG-32, Aloe Barbadensis Leaf Juice, Alumina, Calcium Aluminum Borosilicate, Caprylyl Glycol, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Panthenol, Retinyl Palmitate, Stearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Sodium Dehydroacetate, Phenoxyethanol, [+/- (MAY CONTAIN/PEUT CONTENIR): Mica, Titanium Dioxide/CI 77891, Iron Oxides/CI 77491, CI 77492, CI 77499]

  • PRINCIPAL DISPLAY PANEL


    image of product

    Enter section text here

  • INGREDIENTS AND APPEARANCE
    WET N WILD FERGIE BB CREAM SPF 15 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ALCOHOL (UNII: 3K9958V90M)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12027-105-1130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/31/2013
    Labeler - Markwins Beauty Products Inc. (135407760)
    Registrant - Markwins Beauty Products Inc. (135407760)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Formula Inc825048945manufacture(12027-105)

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