Label: ADVANCED REVITAL- avobenzone, homosalate, octocrylene lotion

  • 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 March 19, 2020

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  • ACTIVE INGREDIENT

    Active ingredients
    Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 1.86%, Oxybenzone 1.8%

  • PURPOSE

    Purpose
    Sunscreen

  • INDICATIONS & USAGE

    Use

    • provides moderate protection against sunburn
  • WARNINGS

    Warnings
    For external use only

  • WHEN USING

    When using this product

    • keep out of eyes. Rinse with water to remove.
  • STOP USE

    Stop use and ask a doctor if

    • rash or irritation develops and lasts
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply smoothly on cleansed skin before sun exposure and as needed
    • children under six months of age: ask a doctor
  • CLINICAL STUDIES

    Other information

    • dermatologist and allergy tested
  • GENERAL PRECAUTIONS

    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
    • may stain some fabrics
  • STORAGE AND HANDLING

    • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)
  • INACTIVE INGREDIENT

    Inactive ingredients
    aqua (water/eau), polyacrylate-15, polyacrylate-17, C20-22 alkyl phosphate, C20-22 alcohols, trisiloxane, dimethicone, cyclopentasiloxane, dimethicone crosspolymer, cetyl palmitate, glycerin, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, dicaprylyl carbonate, C14-22 alcohols, C12-20 alkyl glucoside, propylheptyl caprylate, acetyl tetrapeptide-9, phenoxyethanol, cetyl alcohol, caprylyl glycol, 1,2 hexanediol, triethanolamine, xanthan gum, trisodium ethylenediamine disuccinate, parfum, bisabolol, panax ginseng root extract, lycium barbarum fruit extract, aloe barbadensis leaf juice, camellia oleifera leaf extract, butylene glycol, allantoin, tocopheryl acetate, limonene, butylphenyl methylpropional

  • PRINCIPAL DISPLAY PANEL

    Age Defying Triple Benefit Lotion

  • INGREDIENTS AND APPEARANCE
    ADVANCED REVITAL 
    avobenzone, homosalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-277
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.9 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.93 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TETRAPEPTIDE-21 (UNII: 179JUC43HU)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
    C12-16 ALCOHOLS (UNII: S4827SZE3L)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    TREHALOSE (UNII: B8WCK70T7I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SQUALANE (UNII: GW89575KF9)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    MONTMORILLONITE (UNII: A585MN1H2L)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    BROCCOLI SPROUT (UNII: 128UH9LOAE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-277-011 in 1 BOX01/01/2018
    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 finalpart35205/01/2017
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.079711683manufacture(54473-277)
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