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Deep Tan Perfecting Makeup Broad Spectrum SPF 25 (Merle Norman Cosmetics, Inc)

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EMULSION 30 mL in 1 BOTTLE (57627-137-01) Label Information

Complete Deep Tan Perfecting Makeup Broad Spectrum SPF 25 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

    Warnings

    · 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), Cyclopentasiloxane, 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 022212.


  • PRINCIPAL DISPLAY PANEL

    image of carton artimage of bottle art

    Deep Tan Perfecting Makeup Broad Spectrum SPF 25
    Merle Norman Established in Los Angeles since 1931
    30 mL 1 Fl. Oz.


  • INGREDIENTS AND APPEARANCE
    DEEP TAN PERFECTING MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
    octinoxate, titanium dioxide emulsion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-137
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 71 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    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)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    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:57627-137-02 1 in 1 CARTON 08/22/2012
    1 NDC:57627-137-01 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(57627-137)