Label: ALABASTER BEIGE PERFECTING MAKEUP SPF 25 MERLE NORMAN- octinoxate, titanium dioxide emulsion

  • NDC Code(s): 57627-185-01
  • Packager: Merle Norman Cosmetics, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 18, 2021

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  • 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), 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 022212.

  • 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
    ALABASTER BEIGE PERFECTING MAKEUP SPF 25  MERLE NORMAN
    octinoxate, titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.13 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57627-185-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/22/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/22/2012
    Labeler - Merle Norman Cosmetics, Inc (008479388)
    Registrant - Merle Norman Cosmetics, Inc (008479388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Merle Norman Cosmetics, Inc008479388manufacture(57627-185)
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