SUNSCREEN BROAD SPECTRUM SPF 50 VI AESTHETICS (ZINC OXIDE, OCTINOXATE) CREAM [VI MEDICAL PRODUCTS, INC]

SUNSCREEN BROAD SPECTRUM SPF 50 VI AESTHETICS (ZINC OXIDE, OCTINOXATE) CREAM [VI MEDICAL PRODUCTS, INC]
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NDC 70484-005-01, 70484-005-02, 70484-005-03, 70484-005-04
Set ID 73620765-c7c0-4bd7-82a9-00022773c928
Category HUMAN OTC DRUG LABEL
Packager Vi Medical Products, INC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients             Purpose

    Octinoxate  7.5% .............  Sunscreen

    Zinc Oxide  10% ............... Sunscreen

  • PURPOSE

    Uses

    • 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.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.
  • INDICATIONS & USAGE

    • Stop use and ask a doctor if rash occurs
  • WARNINGS

    Warnings

    • For external use only
    • When using this product keep out of eyes. Rinse with water to remove
  • DOSAGE & ADMINISTRATION


    Directions

    • Apply evenly 15 minutes before sun exposure
    • Reapply at least every 2 hours or after towel drying, swimming or sweating
    • Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including
    • Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10am-2pm

    • wear long-sleeved shirts, pants, hats, and sunglasses

    • children under 6 months of age: Askj a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, C12-15, Alkyl Benzoate, Octyldodecly Neopentanoate, Polysorbate 60, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG - 100 Stearate, Coconut Alkanes, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Dimethicone, Aloe Barbadensis Leaf Extract, Citrus Grandis Fruit Extract, Anthemis Nobilis Flower Extract, Pueraria Lobata Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Benzyl Alcohol, Ehtylhexylglycerin, Phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    VI Derm

    SPF 50+ Cream

    Sunscreen Broad Spectrum

    59 ml/2 FL OZ

    Label 2oz.

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN BROAD SPECTRUM SPF 50  VI AESTHETICS
    zinc oxide, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70484-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Glycerin (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PUMMELO (UNII: ET1TN5W71X)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70484-005-021 in 1 BOX03/26/2015
    1NDC:70484-005-0130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70484-005-041 in 1 BOX03/26/2015
    2NDC:70484-005-0359 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/26/2015
    Labeler - Vi Medical Products, INC (063910521)
    Registrant - VEGE-KURL, INC (021072509)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEGE-KURL, INC021072509manufacture(70484-005)

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