Label: LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN - NUDE- meradimate, octinoxate cream

  • 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 July 10, 2015

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  • Drug Facts

  • Active Ingredients

    Meradimate (3.5%)

    Octinoxate (7.5%)

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.

  • 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.

    Stop use and ask a doctor

    if rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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
    • 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 a broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun especially from 10 AM to 2 PM.
    • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months: Ask a doctor.
  • Other information:

    • protect this product from excessive heat and direct sun.
  • Inactive ingredients

    water, cetearyl alcohol, peg-40 castor oil, dimethicone, polyglyceryl-4 isostearate, cyclomethicone, dea-cetyl phosphate, hexyl laurate, emu oil, tocopheryl acetate, cetyl peg/ppg-10/1 dimethicone, polysorbate 60, diazolidinyl urea, magnesium aluminum silicate, sodium ascorbate, propylparaben. may contain:iron oxides, titanium dioxide, mica

  • Questions or comments?

    Call 1-888-637-2437, M - F 9am - 5pm CST.

  • Product Label

    Packet

  • INGREDIENTS AND APPEARANCE
    LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN - NUDE 
    meradimate, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-1403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE35 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    EMU OIL (UNII: 344821WD61)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65342-1403-02 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/09/2015
    Labeler - Gurwitch Products, L.L.C. (884875246)
    Establishment
    NameAddressID/FEIBusiness Operations
    Qualis Packaging078387992pack(65342-1403)
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