Label: ADVANCED FIRMING AND ANTI WRINKLE- ensulizole, octinoxate cream

  • 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 February 26, 2011

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  • Active ingredient

    Ensulizole, 2.0%

    Octinoxate, 7.5%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
  • Warnings

    For external use only

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    if rash or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Every day, smooth gently onto face and neck until thoroughly absorbed. Use in the AM, alone or under makeup.
    • Children under 6 months of age: ask a doctor.
  • Other information

    Moderate protection against sunburn

  • Inactive ingredients

    water, cyclopentasiloxane, cyclohexasiloxane, glycerin, titanium dioxide, alumina, simethicone, squalane, glyceryl stearate, PEG-100 stearate, simmondsia chinensis (jojoba) seed oil, beeswax, triethanolamine, myristyl myristate, cetearyl alcohol, stearic acid, polyglyceryl-10 pentastearate, behenyl alcohol, sodium steroyl lactylate, tocopheryl acetate (vitamin E), dipalmitoyl hydroxyproline, butylene glycol, carbomer, polysorbate-20, palmitoyl oligopeptide, palmitoyl tetrapeptide-7, lecithin, soy isoflavones, polysorbate 80, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, steareth-2, phenoxyethanol, polyacrylate-13, polyisobutene, glycine soja (soybean) protein, fragrance, xanthan gum, retinyl palmitate (vitamin A), allantoin.

  • Principal Display Panel

    Compare to L'Oreal® Advanced Revitalift® Complete Day Cream SPF18 ingredients

    Advanced Firming & Anti-Wrinkle

    Day Cream SPF 18

    with encapsulated Pro-Vitamin A & Matrixyl™ & Sepilift™

    Advanced Firming & Anti-Wrinkle Cream Carton

    Advanced Firming & Anti-Wrinkle Cream Carton

  • INGREDIENTS AND APPEARANCE
    ADVANCED FIRMING AND ANTI WRINKLE 
    ensulizole, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0378
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0378-01 in 1 CARTON
    148 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/10/2010
    Labeler - Rite Aid Corporation (014578892)
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