VASSEUR SKINCARE DAY MATTE SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [VASSEUR INTERNATIONAL INC]

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VASSEUR SKINCARE DAY MATTE SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [VASSEUR INTERNATIONAL INC]
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NDC 69749-640-01
Set ID b805f352-60b2-409f-ab97-5cc151a66e9e
Category HUMAN OTC DRUG LABEL
Packager Vasseur International Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 6.00%

    Zinc Oxide 6.00%

    Sunscreen

  • Uses:

    • Helps prevent sunburn.
    • If used as directed with other sun protection measure (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 consult physician

    if irritation or rash develops.

    Keep out of reach of children.

    If product is swallowed, get medical attention or contact poison control center immediately.

  • Directions:

    Apply liberally 15-minutes before sun exposure.

    Reapply:

                    • At least every two-hours.

                    • Immediately after swimming, sweating or towel drying.

    SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

                    • Limit time in the sun, especially between 10am and 2pm.

                    • Wear long sleeve shirts, pants, hats and sunglasses.

                    • For children under 6-months, consult a physician.

  • Other Ingredients:

    ALOE BARADENSIS LEAF (ALOE VERA GEL) JUICE, AQUA (DELONIZED WATER), CAMELLIA SINENSIS (GREEN TEA) EXTRACT, ETHYLHEXYLGLYCERIN, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) OIL, LECITHIN, OCTYL PALMITATE, PHENOXYETHANOL, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, SESAMUM INDICUM (SESAME) SEED OIL, SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE, THEOBROMA CACAO (COCOA) BUTTER, TOCOPHEROL (VITAMIN E), XANTHAN GUM

  • Product Label

    Box

  • INGREDIENTS AND APPEARANCE
    VASSEUR SKINCARE DAY MATTE SPF30 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69749-640
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SESAME OIL (UNII: QX10HYY4QV)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69749-640-01113 g in 1 BOTTLE; Type 0: Not a Combination Product02/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/07/2015
    Labeler - Vasseur International Inc (150096316)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(69749-640)
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