Label: CVS DRY SKIN THERAPY WITH SPF 15- ensulizole, octisalate and 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 July 19, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients: Ensulizole, 1.0%, Octisaltae, 4.0%, Octocrylene, 1.0%                        


  • PURPOSE


    CVS/pharmacy Dry Skin Therapy Daily Protection Body Lotion provides skin
    with intense moisturizers and SPF 15. This helps keep your skin moisturized
    and protected from incidental exposure to the sun's harmful rays. Antioxidants
    and Vitamine E moisturize dry skin, while a blend of sunscreens provide wide
    ranging UVA/UVB protection.

    -Formula contains a blend of sunscreens, including titanium dioxide, providing
    broad spectrum UVA/UVB protection
    - Enriched with antioxidants
    - Non-greasy formula
    - Fragrance free
  • KEEP OUT OF REACH OF CHILDREN


    Warnings: Keep out of reach of children. 
  • INDICATIONS & USAGE


    CVS/pharmacy Dry Skin Therapy Daily Protection Body Lotion provides skin
    with intense moisturizers and SPF 15. This helps keep your skin moisturized
    and protected from incidental exposure to the sun's harmful rays. Antioxidants
    and Vitamine E moisturize dry skin, while a blend of sunscreens provide wide
    ranging UVA/UVB protection.

    -Formula contains a blend of sunscreens, including titanium dioxide, providing
    broad spectrum UVA/UVB protection
    - Enriched with antioxidants
    - Non-greasy formula
    - Fragrance free
  • WARNINGS

    Warnings

    Keep out of reach of children.

    For external use only.
    Avoid contact with eyes.
    Stop use and consult a doctor if irritation develops.
  • DOSAGE & ADMINISTRATION


    Directions 


    Apply generously to hands and body daily.

    Reapply as needed.
  • INACTIVE INGREDIENT

    Other Ingredients

    Water, Glycerin, Sodium Carboxylmethyl Beta-Glucan, Dimethicone, Isopropyl Isostearate,
    Polyacrylamide, Triethanolamine, Boron Nitride, Sorbitan Stearate, Cetyl Alcohol, Alumina,
    Simethicone, C13-14 Isoparaffin, Panthenol, Tocopheryl Acetate, Stearyl Alcohol, Titanium Dioxide,
    Behenyl Alcohol, Dimethiconol, Cyclomethicon, Benzyl Alcohol, Diazolidinyl Urea, Propylene Glycol,
    Laureth-7, Propylparaben, Disodium EDTA, PEG-100 Stearate, Stearic Acid,  Methylparaben, Cetaryl Alcohol,
    Cetaryl Glucoside
  • PRINCIPAL DISPLAY PANEL

    c
  • INGREDIENTS AND APPEARANCE
    CVS DRY SKIN THERAPY WITH SPF 15 
    ensulizole, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-317
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE10 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TEA LEAF (UNII: GH42T47V24)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-317-49400 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/19/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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