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Bare Perfecting Makeup (Merle Norman Cosmetics, Inc)

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EMULSION 1 BOTTLE in 1 CARTON (57627-123-02) > 30 mL in 1 BOTTLE (57627-123-01) Label Information

Complete Bare Perfecting Makeup Information

  • ACTIVE INGREDIENT

    Active Ingredients purpose
    Octinoxate 7.5% Sunscreen
    Titanium Dioxide 7.1% 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

    Keep out of reach of children. If swallowed, get medical help or
    contact a Poison Control Center right away.

    Stop use and ask a doctor if rash occurs and persists

    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.

    Directions
    · Apply liberally 15 minutes before sun exposure
    · Reapply at least every 2 hours
    · Use a water resistant sunscreen if swimming or sweating

    · 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 broad spectrum SPF of 15 or higher and other sun protection measures
    including:
    · limit time in the sun, especially from 10 a.m. - 2 p.m.
    · wear long-sleeve shirts, pants, hats, and sunglasses
    · Children under 6 months: Ask a doctor

    Inactive Ingredients
    Water (Aqua), Cyclopenta siloxane, Clyclohexasiloxane, Isododecane, Alcohol Denat., Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Acrylates/Dimethicone Copolymer, Silica, Acrylates Copolymer, Sodium Myristoyl Glutamate, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Disteardimonium Hectorite, Caprylyl Glycol, Aluminum Oxide, Stearic Acid, Propylene Glycol, Propylene Carbonate, Tetrasodium EDTA, Methylisothiazolinone,
    May Contain: Iron Oxides, Titanium Dioxide, Triethoxycaprylylsilane


  • PRINCIPAL DISPLAY PANEL

    image of carton artimage of bottle art

    Perfecting Makeup Broad Spectrum SPF 25
    Merle Norman

    Established in Los Angeles since 1931
    30 mL 1 Fl. Oz.


  • INGREDIENTS AND APPEARANCE
    BARE PERFECTING MAKEUP  MERLE NORMAN
    octinoxate, titanium dioxide emulsion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-123
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.25 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.13 g  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ISODODECANE (UNII: A8289P68Y2)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57627-123-02 1 in 1 CARTON 08/22/2012
    1 NDC:57627-123-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 08/22/2012
    Labeler - Merle Norman Cosmetics, Inc (008479388)
    Registrant - Merle Norman Cosmetics, Inc (008479388)
    Establishment
    Name Address ID/FEI Business Operations
    Merle Norman Cosmetics, Inc 008479388 manufacture(57627-123)