Label: MAYBELLINE DREAM URBAN COVER FULL COVERAGE PROTECTIVE MAKE-UP SPF 50 ANTIOXIDANT-ENRICHED POLLUTION PROTECTION- homosalate, octisalate and octocrylene emulsion

  • NDC Code(s): 49967-518-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 30, 2024

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

  • Active ingredients

    Homosalate 10%

    Octisalate 5%

    Octocrylene 4%

  • 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

    Flammable until dry.

    Do not use near fire, flame, or heat.

  • 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

    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
  • Questions or comments?

    1-800-322-2036

    Monday - Friday (9 a.m. - 5 p.m. EST)

  • Inactive ingredients

    water, dimethicone, propanediol, alcohol denat., niacinamide, vinyl dimethicone/methicone silsesquioxane crosspolymer, synthetic flourphlogopite, PEG-30 dipolyhydroxystearate, tocopherol, caffeine, disteardimonium hectorite, polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, scutellaria baicalensis root extract, aluminum hydroxide, fragrance, limonene, benzyl salicylate, citral; may contain: titanium dioxide, iron oxides

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MAYBELLINE DREAM URBAN COVER FULL COVERAGE PROTECTIVE MAKE-UP SPF 50 ANTIOXIDANT-ENRICHED POLLUTION PROTECTION 
    homosalate, octisalate and octocrylene emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-518
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALCOHOL (UNII: 3K9958V90M)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAFFEINE (UNII: 3G6A5W338E)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-518-0130 mL in 1 TUBE; Type 0: Not a Combination Product06/01/201911/12/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/201911/12/2024
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA PRODUCTS, INC.624244349manufacture(49967-518)