Label: LOREAL PARIS WRINKLE EXPERT AGE DEFENSE 55 PLUS BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene lotion

  • NDC Code(s): 49967-291-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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

  • Active ingredients

    Avobenzone 3%

    Homosalate 5%

    Octisalate 5%

    Octocrylene 7.2%

  • 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 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, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, stearic acid, phenoxyethanol, palmitic acid, ammonium polyacryloyldimethyl taurate, dicaprylyl carbonate, steareth-100, phenylethyl resorcinol, capryloyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, fragrance, tocopherol, calcium PCA, sodium hyaluronate, ascorbyl glucoside, myristic acid, sodium hydroxide

  • PRINCIPAL DISPLAY PANEL

    image of a label

    image of a label
  • INGREDIENTS AND APPEARANCE
    LOREAL PARIS WRINKLE EXPERT AGE DEFENSE 55 PLUS BROAD SPECTRUM SPF 30 SUNSCREEN 
    avobenzone, homosalate, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-291
    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) Homosalate50 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene72 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    PHENYLETHYL RESORCINOL (UNII: G37UFG162O)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CALCIUM PIDOLATE (UNII: 7Y2LVU5EKK)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-291-011 in 1 CARTON05/21/2020
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/21/2020
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA Products Inc624244349manufacture(49967-291)