Label: CVS ADVANCED DEEP SET WRINKLE THERAPY W/SPF15- ensulizole and octinoxate 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 July 19, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Ensulizole, 1.8%, Octinoxate, 7.5%       


  • PURPOSE


    CVS/pharmacy Advanced Deep-Set Wrinkle Day Therapy

    What age related skin issues does our advanced formula address?

    Deep-set wrinkles commonly appear on the forehead, brow and in the form
    of frown lines and crow's feet. With daily use, our deep wrinkle lotion evens out the
    surface of wrinkles and decreases their appearance.

    Our Pro-Retinol formula also provides the advanced skin protection of SPF 15 sunscreen
    to help protect the skin from UV damage.

    Multi-Action Benefits

    Smooths Skin:

    - Pro-Retinol Vitamin A firms and tones skin, improving elasticity.
    - Encapsulated technology provides continuous benefits in fighting the
    signs of aging
    - Diminishes appearance of deep-set wrinkles.

    Hydrates and Protects Dry Skin:

    - Essential nutrients replenish moisture, maintaining skin's natural balance and
    enhancing softness
    - SPF 15 helps protect the skin
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children.
  • INDICATIONS & USAGE



    Recomended regimen

    Step 1 Cleanse skin thoroughly

    Step 2 Apply CVS/pharmacy Day and Night Eye Cream

    Step 3 AM: Follow-up with CVS/pharmacy Deep-Set Wrinkle Day Treatment.
               PM: CVS/pharmacy Deep-Set Wrinkle Night Cream.

    How and When to Use

    Every morning after thoroughly cleansing skin, apply alone or under makeup.
    Gently smooth onto face and neck until completely absorbed.

    To use as a sunscreen apply to face prior to sun exposure
  • WARNINGS

    Warnings

    For external use only, not to be swallowed. Avoid contact with eyes.
    If contact occurs, rinse eyes thoroughly with water. Discontinue use if signs of irritation
    or rash appear. If irritation or rash persists, consult a doctor.

    Keep out of reach of children.
  • DOSAGE & ADMINISTRATION


    Recommended Application

    Step 1     Cleanse skin thoroughly

    Step 2 Apply CVS/Pharmacy Day and NIght Cream

    Step 3 AM: Follow-up with CVS?Pharmacy Advanced Anti-Wrinkle and Firming Day Cream
                PM: Follow-up with CVS/Pharmacy Advanced Anti-Wrinkle and Firming Night Cream

    How and When to Use

    Every day prior to sun exposure, gently smooth onto face and neck until completely absorbed. Use in the morning; alone or under makeup.

    To use as a sunscreen, apply to face prior to sun exposure.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, C12-15 Alkyl Benzoate, Fragrance, Cetyl Alcohol, PolyGlyceryl-10 Pentastearate,
    Behenyl Alcohol, Sodium Stearoyl Lactylate, Retinyl Palmitate, Butylene Glycol,
    Titanium Dioxide, Alumina, Simethicone, Potassium Cetyl Phosphate, Propylene Glycol,
    Triethanolamine, Tocopheryl Acetate, Cetearyl Alcohol, Butylated Hydroxytoluene, Panthenol,
    Xanthan Gum, Diazolidinyl Urea, Cetearyl Glocoside, Chamomila Recutita (Matricaria) Flower
    Extract, Dimethicone, Disodium EDTA, Propylparaben, Glycerin, Methylparaben, Red 33

  • PRINCIPAL DISPLAY PANEL


    c

  • INGREDIENTS AND APPEARANCE
    CVS ADVANCED DEEP SET WRINKLE THERAPY W/SPF15 
    ensulizole and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE18 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-063-0950 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/19/2011
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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