Label: LAURA MERCIER FLAWLESS SKIN REPAIR OIL FREE DAY BROAD SPECTRUM SPF 15- octinoxate lotion

  • 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 5, 2015

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  • Drug Facts

  • Active ingredients

    Oxtinoxate 3.5%

    Purpose

    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 liberly 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 this product in this container from excessive heat and direct sun.

  • Inactive ingredients

    water, sea water, glycerin, polymethylsilsesquioxane, dicaprylyl carbonate, dimethicone, butylene glycol, polyglyceryl-10 isostearate, squalane, trehalose, ethyl oleate, butyl methoxydibenzoylmethane, phenoxyethanol, polycrylamide, beeswax, benzophenone-3, c13-14 isoparaffin, carbomer, arginine, disodium EDTA, linalool, tocopheryl acetate, laureth-7, pyrus cydonia seed extract, glycosphingolipids, sodium polyacrylate, glycerylamidoethyl methacrylate/stearyl methacrylate copolymer, synthetic fluorphlogopite, aluminum hydroxide, hydrolyzed collagen, caprylic/capric triglyceride, zinc oxide, dipotassium glycyrrhizate, sodium ascorbyl phosphate, yeast beta-glucan, yeast extract, hydrogen dimethicone, camellia sinensis leaf powder, oligopeptide-6, hexapeptide-3, tripeptide-3.

  • Questions or comments?

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

  • REPAIR OIL-FREE DAY LOTION BROAD SPECTRUM SPF 15

    This advanced anti-aging daily oil-free lotion helps repair skin, for smoother, radiant, younger looking complexion while providing environmental protection. Repair Oil-Free Day Lotion Broad Spectrum SPF 15 helps:

    • Prevent and diminish the appearance of fine lines and wrinkles with Green Tea Extract
    • Provide lightweight, oil-free hydration with Refined Deep Sea Water

    Direction for use: Apply every morning to cleansed skin after Flawless Skin serum.

    DERMATOLOGIST TESTED. NON COMEDOGENIC.

    laura mercier

    DIST. GURWITCH PRODUCTS L.L.C.

    PO BOX 7568.

    NEW YORK, NY 10150

    MADE IN JAPAN    lauramercier.com

  • Product labels

    laura mercier  flawless skin  REPAIR OIL-FREE  DAY LOTION  BROAD SPECTRUM  SPF 15 SUNSCREEN  1.7 FL.OZ./50ml

    DayLotion_CartonDayLotion_Bottle

  • INGREDIENTS AND APPEARANCE
    LAURA MERCIER FLAWLESS SKIN REPAIR OIL FREE DAY BROAD SPECTRUM SPF 15 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-5000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SQUALANE (UNII: GW89575KF9)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OXYBENZONE (UNII: 95OOS7VE0Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ARGININE (UNII: 94ZLA3W45F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65342-5000-050 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/30/2014
    Labeler - Gurwitch Products, LLC (884875246)
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