Label: MAYBELLINE NEW YORK FIT ME FOUNDATION DEWY PLUS SMOOTH SPF 18 SUNSCREEN- octinoxate lotion

  • NDC Code(s): 49967-969-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • Active ingredient

    Octinoxate 7%

  • Purpose

    Sunscreen

  • Use

    • helps prevent sunburn
  • 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 help prevent sunburn, not skin cancer or early skin aging.

  • 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

    ● reapply at least every 2 hours

    ● use a water resistant sunscreen if swimming or sweating

    ● 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, glycerin, isotridecyl isononanoate, PEG-9 polydimethylsiloxyethyl dimethicone, disteardimonium hectorite, dimethicone/polyglycerin-3 crosspolymner, sodium chloride, PEG-10 dimethicone, phenoxyethanol, methylparaben, disodium stearoyl glutamate chlorphenesin, disodium, EDTA, acrylates copolymer, propylparaben, fragrance, tocopherol ascorbyl palmitate, aluminum hydroxide, butylparaben PEG-9, ethylparaben, dipropylene glycol, alphaisomethyl ionone; may contain: titanium dioxide, iron oxides

  • PRINCIPAL DISPLAY PANEL

    image of a label

    image of a label
  • PRINCIPAL DISPLAY PANEL

    image of a label

    image of a label
  • INGREDIENTS AND APPEARANCE
    MAYBELLINE NEW YORK FIT ME FOUNDATION DEWY PLUS SMOOTH SPF 18 SUNSCREEN 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-969
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-969-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/01/2010
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.624244349manufacture(49967-969)
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