Label: LOREAL PARIS REVITALIFT DERM INTENSIVES INVISIBLE UV FLUID BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene gel

  • NDC Code(s): 49967-011-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 28, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients

    Avobenzone 3%

    Homosalate 15%

    Octisalate 5%

    Octocrylene 10%

  • 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:

    • shake well
    • 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

  • Inactive ingredients

    water, alcohol denat., glycerin, styrene/acrylates copolymer dimethicone, butyloctyl salicylate, sodium dodecylbenzenesulfonate, phenoxyethanol, phenylethyl resorcinol, adenosine, PEG-8 laurate, PEG-20, trisodium ethylenediamine disuccinate, sclerotium gum, pullulan, ammonium acryloyldimethyltaurate/vp copolymer, xanthan gum, isocetyl stearate, caprylyl glycol, carbomer, cetearyl glucoside, inulin lauryl carbamate

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    LOREAL PARIS REVITALIFT DERM INTENSIVES INVISIBLE UV FLUID BROAD SPECTRUM SPF 50 SUNSCREEN 
    avobenzone, homosalate, octisalate, and octocrylene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate150 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYLETHYL RESORCINOL (UNII: G37UFG162O)  
    ADENOSINE (UNII: K72T3FS567)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-011-011 in 1 CARTON09/30/2022
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/30/2022
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beauty Manufacturing Solutions Corp.783200723manufacture(49967-011) , pack(49967-011)