DAILY MOISTURIZING SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [VIVIER PHARMA, INC.]

DAILY MOISTURIZING SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [VIVIER PHARMA, INC.]
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NDC 67226-2016-5
Set ID 298a9ef9-5818-4ea3-b27f-e714713cc623
Category HUMAN OTC DRUG LABEL
Packager Vivier Pharma, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug facts

  • Active ingredients

    Octinoxate - 7.5%
    Octyl Salicylate - 3%

    Benzophenone-3 - 3%

    Purpose

    Sunscreen

  • Uses

    • Moisturizing cream with sunscreen. • Helps prevent sunburn and provides a sun protection factor of 15. • 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. • Ideal for daily use; can be applied under makeup.

  • Warnings

    For external use only.

    Do not use

    on damaged or broken skin.

    When using this product

    avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    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

    • Apply daily to face, neck and chest. • Apply to clean, dry skin, liberally and evenly 15 minutes before sun exposure. • Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing. • For use on children less than 6 months of age, consult a healthcare practitioner. • Use a water resistant sunscreen if swimming or sweating.

  • Other information

    Store at room temperature (15-30°C / 59-86°F).

  • Inactive ingredients

    Water/Eau, Squalane, Divinyldimethicone/Dimethicone Copolymer, C12-13 Pareth-23, C12-13 Pareth-3, Xanthan Gum, Caprylyl Glycol, Phenoxyethanol, Glucose, Carrageenans (Chondrus Crispus), Ethylhexylglycerin, Stearyl Alcohol, Tribehenin, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Glycerin, Glyceryl Polyacrylate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cetyl Palmitate, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Tocopheryl Acetate, Propylene Glycol, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Allantoin, Sodium Hyaluronate, Hydrolyzed Glycosaminoglycans, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Ascorbyl Phosphate.

  • Questions?

    Call 1 877 484 8437

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    DAILY MOISTURIZING SPF 15 
    octinoxate, octisalate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    C12-13 PARETH-23 (UNII: J1WW1510L4)  
    C12-13 PARETH-3 (UNII: DMC6N3419L)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    ROSEMARY (UNII: IJ67X351P9)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-2016-51 in 1 BOX05/01/2019
    155 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2019
    Labeler - Vivier Pharma, Inc. (250996550)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermolab Pharma Ltd245414743manufacture(67226-2016)

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