Label: LAURA MERCIER FLAWLESS SKIN REPAIR DAY BROAD SPECTRUM SPF 15- 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 January 6, 2015

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

  • Drug Facts

  • Active ingredients

    Octinoxate 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, trehalose, dimethicone, squalane butylene glycol, polyglyceryl-10 isostearate, dicaprylyl carbonate, cetearyl alcohol, beeswax, vitis vinifera (grape) seed oil, butyl methoxydibenzoylmethane, phenoxyethanol, benzophenone-3, polycrylamide, carbomer, c13-14 isoparaffin, tocopheryl acetate, pvm/ma decadiene crosspolymer, disodium EDTA, hydrolyzed xylan, linalool, potassium hydroxide, pyrus cydonia seed extract, laureth-7, glycosphingolipids, glycerylamidoethyl methacrylate/stearyl methacrylate copolymer, sodium polyacrylate, synthetic fluorphlogopite, aluminum hydroxide, hydrolyzed collagen, ethyl oleate, dipotassium glycyrrhizate, argania spinosa kernel oil, caprylic/capric triglyceride, zinc oxide, tocopherol, yeast extract, yeast beta-glucan, sodium ascorbyl phosphate, hydrogen dimethicone, camellia sinensis leaf powder, oligopeptide-6, tripeptide-3, hexapeptide-3.

  • Questions or comments?

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

  • REPAIR DAY CREME BROAD SPECTRUM SPF 15 SUNSCREEN

    This advanced anti-aging daily moisturizer helps repair skin, for smoother, radiant, younger looking complexion while providing environmental protection. Repair Day Creme Broad Spectrum SPF 15 Sunscreen helps:

    • Prevent and diminish the appearance of fine lines and wrinkles with Green Tea Extract
    • Smooth skin texture with Hydrolyzed Xylan and boost hydration with Argan Oil
    • Repair the lipid barrier with minerals in Deep Sea Water

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

    DERMATOLOGIST TESTED. NON COMEDOGENIC.

  • Product labels

    laura mercier flawless skin REPAIR DAY CREME  BROAD SPECTRUM SPF 15 SUNSCREEN  NET WT. 1.7 OZ./50g

    Day Creme Broad Spectrum SPF 15 Sunscreen, 50mL - CartonDay Creme Broad Spectrum SPF 15 Sunscreen, 50mL - JarDay Creme Broad Spectrum SPF 15 Sunscreen, 50mL - Label

  • INGREDIENTS AND APPEARANCE
    LAURA MERCIER FLAWLESS SKIN REPAIR DAY BROAD SPECTRUM SPF 15 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-5100
    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)  
    TREHALOSE (UNII: B8WCK70T7I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SQUALANE (UNII: GW89575KF9)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    OXYBENZONE (UNII: 95OOS7VE0Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CYDONIA OBLONGA SEED (UNII: JXU526QH1V)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65342-5100-050 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/31/2014
    Labeler - Gurwitch Products, LLC (884875246)