Label: PREVAGE ANTI-AGING MOISTURE CREAM- octinoxate, octisalate, oxybenzone, octocrylene, avobenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 9, 2022

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  • Inactive ingredients

    WATER/AQUA/EAU, DIMETHICONE, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, ISOSTEARYL NEOPENTANOATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, THEOBROMA CACAO (COCOA) SEED BUTTER, CYCLOPENTASILOXANE, PROPYLENE GLYCOL, PPG-2 ISOCETETH-20 ACETATE, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, ACRYLAMIDE/SODIUM ACRYLATE COPOLYMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, CARBOMER, CETEARYL ALCOHOL, CETEARYL DIMETHICONE CROSSPOLYMER, CYCLOHEXASILOXANE, DIMETHICONE CROSSPOLYMER, DIMETHICONOL, ERGOTHIONEINE, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, HYDROGENATED LECITHIN, HYDROGENATED PHOSPHATIDYLCHOLINE, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, MICA, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, PARFUM/FRAGRANCE, PEG-8, PHENYL TRIMETHICONE, PHOSPHOLIPIDS, POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE, POLYQUATERNIUM-51, POLYSORBATE 60, RETINYL LINOLEATE, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM PCA, SUCROSE, TREHALOSE, TRIDECETH-6, UREA, XANTHAN GUM, BHT, ALPHA-ISOMETHYL IONONE, LINALOOL, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, PROPYLPARABEN, IRON OXIDES (CI 77492), RED 4 (CI 14700), TITANIUM DIOXIDE (CI 77891), YELLOW 5 (CI 19140)

  • Active Ingredient Section

    OCTINOXATE 7.5%

    OCTISALATE 5.0%

    OXYBENZONE 5.0%

    OCTOCRYLENE 2.2%

    AVOBENZONE 2.0%

  • 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.

  • WHEN USING

    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

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

  • PRINCIPAL DISPLAY PANEL

    Prevage day cream

  • INGREDIENTS AND APPEARANCE
    PREVAGE ANTI-AGING MOISTURE CREAM 
    octinoxate, octisalate, oxybenzone, octocrylene, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-688
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.2 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE (UNII: OV1BT2N8RC)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    MICA (UNII: V8A1AW0880)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    DIMETHICONE 1000 (UNII: MCU2324216)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
    TREHALOSE (UNII: B8WCK70T7I)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    UREA (UNII: 8W8T17847W)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    RETINYL LINOLEATE (UNII: 61911N8D6W)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-688-171 g in 1 JAR; Type 0: Not a Combination Product01/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/02/2020
    Labeler - Revlon Consumer Products Corp (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    ENGLEWOOD LAB, INC080987545manufacture(10967-688)