Label: SUNSCREEN BROAD SPECTRUM SPF 50 VI AESTHETICS- zinc oxide, octinoxate cream

  • Category: HUMAN OTC DRUG LABEL

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 March 16, 2017

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  • 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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