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

  • NDC Code(s): 11090-099-01
  • Packager: Beauty Manufacturing Solutions Corp.
  • 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 December 6, 2022

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

  • ACTIVE INGREDIENT

    Avobenzone 3%

    Homosalate 15%

    Octisalate 5%

    Octocrylene 10%

  • PURPOSE

    Avobenzone 3%-Sunscreen

    Homosalate 15%-Sunscreen

    Octisalate 5%-Sunscreen

    Octocrylene 10%-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

    keep out of eyes. Rinse with water to remove.

  • STOP USE

    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 INGREDIENT

    water, alcohol denat.,glycerin, styrene/acrylates copolymer dimethicone, butyloctyl salicylate,silica, Isononyl Isononanoate,Isopropyl Myristate, Cetearyl Alcohol, Calcium Aluminum Borosilicate,Tocopherol,Adenosine,Phenyl Resorcinol,Trisodium Ethylenediamine Disuccinate,Ascorbyl Glucoside,isocetyl stearate,ammonium acryloyldimethyltaurate/vp copolymer,caprylyl glycol,carbomer,cetearyl glucoside, inulin lauryl carbamate,Lecithin,PEG-20,PEG-8 laurate,pullulan,sclerotium gum,sodium dodecylbenzenesulfonate, Sodium Stearoyl Glutamate,t-Butyl Alcohol,Xanthan Gum,Phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    Principle Display Panel

  • 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:11090-099
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE150 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    ADENOSINE (UNII: K72T3FS567)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    PHENYLETHYL RESORCINOL (UNII: G37UFG162O)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)  
    ISOCETYL ISOSTEARATE (UNII: UQP66X2A3X)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11090-099-011 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 not finalpart35209/30/2022
    Labeler - Beauty Manufacturing Solutions Corp. (783200723)
    Registrant - Beauty Manufacturing Solutions Corp. (783200723)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beauty Manufacturing Solutions Corp.783200723manufacture(11090-099)