Label: ELIZABETH ARDEN, GREAT 8, MOISTURIZER SPF 35- avobenzone, octisalate, homosalate emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2024

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

  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

  • Uses

    - helps provent sunburn

    - if used as directed with other sun protection measures decreases the risk of cancer and early skin aging caused by the sun

  • When using this product

    keep out of eyes. Rinse with water to remove.

  • Stop using and ask a doctor

    if rash occurs.

  • Keep out of reach of children.

    If product is swalled, 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 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 of 15 or higher and other sun protection measures including:

    limit time in the sun, especially from 10am-2pm

    wear long-sleede shirts, pants, hats, and sunglasses

    children under 6 months: ask a doctor

  • WARNINGS

    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 using and ask a doctor if rash occurs
    • keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION

    As needed

  • INDICATIONS & USAGE

    Sunscreen

  • INACTIVE INGREDIENT

    Aqua/water/eau, dipropylene glycol, glycerin, thermus thermophillus ferment, butylene glycol, imperata cylindrica root extract, enantia chlorantha bark extract, marrubium vulgare extract, acrylates/C10-30 alkyl acrylate crosspolymer, ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer, caprylyl glycol, carbomer, dimethylmethoxy chromanol disodium EDTA, hydroxyacetophenone, oleanolic acid, sclareolide, triethanolamine, parfum (fragrance), geraniol, hexyl cinnamal, limonene, linalool, chlorphenesin.

  • PRINCIPAL DISPLAY PANEL

    Great 8

  • INGREDIENTS AND APPEARANCE
    ELIZABETH ARDEN, GREAT 8, MOISTURIZER SPF 35 
    avobenzone, octisalate, homosalate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-665
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
    2'-HYDROXYACETOPHENONE (UNII: 3E533Z76W0)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SCLAREOLIDE (UNII: 37W4O0O6E6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-665-1545 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2018
    Labeler - Revlon (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Revlon, INC809725570manufacture(10967-665)