Label: WET N WILD FERGIE BB CREAM SPF 15- titanium dioxide cream

  • NDC Code(s): 12027-105-11
  • Packager: Markwins Beauty Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Titanium Dioxide 3.8%

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  • 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

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  • 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.

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  • 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]

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  • PRINCIPAL DISPLAY PANEL


    image of product

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  • INGREDIENTS AND APPEARANCE
    WET N WILD FERGIE BB CREAM SPF 15 
    titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:12027-105
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.8 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12027-105-11 30 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 05/31/2013
    Labeler - Markwins Beauty Products Inc. (135407760)
    Registrant - Markwins Beauty Products Inc. (135407760)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Formula Inc 825048945 manufacture(12027-105)
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