Label: CVS PHARMACY CALMING DAILY MOISTURIZER- avobenzone, octinoxate, octisalate 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 November 17, 2015

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

  • Active ingredients

    Avobenzone 3%, Octinoxate 7.5%, Octisalate 2%

    Purpose

    Sunscreen

  • Use(s)

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months: Ask a doctor.
    • Sun Protection Measure. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other information

    Protect this product from excessive heat and direct sun

  • Inactive ingredients

    Water, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Cetearyl Alcohol, Dimethicone, Cyclopentasiloxane, Glycerin, Cyclohexasiloxane, Arachidyl Alcohol, Phenyl Trimethicone, Phenoxyethanol, Cetearyl Glucoside, Panthenol, Benzyl Alcohol, Nylon-10/10, Chrysanthemum Parthenium (Feverfew) Extract, Behenyl Alcohol, Steareth-2, Sodium Cocoyl Amino Acids, Steareth-21, Fragrance, Polyacrylamide, Arachidyl Glucoside, Disodium EDTA, C13-14 Isoparaffin, Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate, Sarcosine, Laureth-7, Ethylhexylglycerin, Iodopropynyl Butylcarbamate, Potassium Aspartate, Magnesium Aspartate.

  • Questions or comments?

    1-800-746-7287

  • Label Copy

    Image of the label

    Image of the label 2

    Image of the carton

    Image of the carton 2

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY CALMING DAILY MOISTURIZER 
    avobenzone, octinoxate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-598
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    NYLON-12 (UNII: 446U8J075B)  
    TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    SARCOSINE (UNII: Z711V88R5F)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    POTASSIUM ASPARTATE (UNII: OC4598NZEQ)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-598-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:59779-598-05118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/16/2015
    Labeler - CVS PHARMACY (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(59779-598)