Label: FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN- octinoxate, octisalate cream

  • NDC Code(s): 57627-108-01, 57627-108-02, 57627-108-03, 57627-108-04
  • Packager: Merle Norman Cosmetics
  • Category: HUMAN OTC DRUG LABEL

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 October 20, 2022

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  • ACTIVE INGREDIENT

    Active ingredients   Purpose

    OCTINOXATE 7.5%  sunscreen

    OCTISALATE 5.0%   sunscreen

  • PURPOSE

    Uses Helps Prevent Sunburn

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs and persists

  • 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 canceror 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.

  • DOSAGE & ADMINISTRATION

    Directions

    For Sunscreen use:

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

  • INACTIVE INGREDIENT

    Inactive ingredients

    Cyclopentasiloxane, Dimethicone Crosspolymer, Trisiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Cyclomethicone, Palmitoyl Oligopeptide, Ascorbyl Palmitate, Retinyl Palmitate, Tocopheryl Acetate, Ceramide 2 , Camellia Oleifera Leaf Extract, PEG-10 Rapeseed Sterol, Phospholipids, C12-15 Alkyl Benzoate, Cyclotetrasiloxane, Water (Aqua), Isoceteth-10, Tribehenin, Butylene Glycol, Silica, Phenoxyethanol.

  • PRINCIPAL DISPLAY PANEL

    Foundation Primer Plus

    SPF 15

    Merle Norman

    35g Net Wt. 1.25 OZ

    carton

    tube

  • INGREDIENTS AND APPEARANCE
    FOUNDATION PRIMER PLUS SPF 15   MERLE NORMAN
    octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.63 g  in 35 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.75 g  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57627-108-021 in 1 BOX04/22/2011
    1NDC:57627-108-0135 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:57627-108-041 in 1 BOX04/22/2011
    2NDC:57627-108-035 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/22/2011
    Labeler - Merle Norman Cosmetics (008479388)
    Registrant - Merle Norman Cosmetics (008479388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Merle Norman Cosmetics008479388manufacture(57627-108)
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