Label: LAURA MERCIER FLAWLESS SKIN MEGA MOISTURE CREME BROAD SPECTRUM SPF 15 SUNSCREEN FOR NORMAL/DRY SKIN- avobenzone and octinoxate cream

  • NDC Code(s): 58411-411-60
  • Packager: Laura Mercier Cosmetics
  • 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 January 3, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 2.0%Sunscreen
    Octinoxate 7.5%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.
  • 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 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months of age: Ask a doctor
  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • Inactive ingredients

    Water, Cyclopentasiloxane, Dimethicone, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Emu Oil, Glycerin, Sorbitol, Cetearyl Alcohol, PEG-40 Castor Oil, Tocopheryl Acetate, Potassium Cetyl Phosphate, Petrolatum, Polysorbate 60, Urea, Sodium Hyaluronate, Allantoin, Sodium Ascorbate, Phenoxyethanol, Methylparaben, Tetrasodium EDTA, Carbomer, Isopropylparaben, Isobutylparaben, Butylparaben, Sodium Dehydroacetate, Aminomethyl Propanol, Propylparaben, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Linalool.

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

    laura mercier

    flawless skin

    MEGA MOISTURE CRÈME
    BROAD SPECTRUM SPF 15 SUNSCREEN

    FOR NORMAL/DRY SKIN

    50 g / NET WT. 1.7 OZ.

    Principal Display Panel - 50 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    LAURA MERCIER FLAWLESS SKIN   MEGA MOISTURE CREME BROAD SPECTRUM SPF 15 SUNSCREEN FOR NORMAL/DRY SKIN
    avobenzone and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone20 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    EMU OIL (UNII: 344821WD61)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    UREA (UNII: 8W8T17847W)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-411-601 in 1 CARTON11/29/2010
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/29/2010
    Labeler - Laura Mercier Cosmetics (193691821)