Label: RENEW MIRRA DEEP MOISTURE DAY- octinoxate and ensulizole cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/11

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

  • Active ingredient

    Ensulizole, 2.0%

    Octinoxate, 7.5%

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  • Purpose

    Sunscreen

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  • Uses

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

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  • 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.
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  • Other information

    Moderate protection against sunburn

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  • 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.

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  • Questions or Comments?

    1-800-632-6900

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  • Principal Display Panel

    SPF 18

    Deep-Moisture

    Day Cream

    hydrates and firms while protecting

    from the sun for wrinkle reduction

    beeswax & soybean protein + pro-vitamin A

    Deep Moisture Day Cream Carton Image 1

    Deep Moisture Day Cream Carton Image 1

    Deep Moisture Day Cream Carton Image 2

    Deep Moisture Day Cream Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    RENEW MIRRA DEEP MOISTURE  DAY
    ensulizole, octinoxate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-378
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    POLYOXYL 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)  
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-378-15 1 in 1 CARTON
    1 48 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 12/30/2010
    Labeler - Kroger Company (006999528)
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