Label: VSHELL SUNSCREEN- sunscreen cream

  • NDC Code(s): 84507-001-01
  • Packager: Guangdong Miaolian Cosmetics Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated July 10, 2024

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

  • SUNSCREEN PACKAGE

    sunscreen

    uses

    1.Active Ingredient: Octocrylene 4%
    Ethylhexyl salicylate 4%
    Diethylhexyl butamido triazone 2%
    Ethylhexyl triazone 2%
    Tocopheryl acetate 1%
    Titanium dioxide/silica/triethoxycaprylylsilane 2%
    2.Purpose: Helps prevent sunburn
    3.Use: 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.
    4.Warnings: For external use only
    5.Do not use: Do not use on damaged or broken skin.
    6.When Using : When using this product
    keep out of eyes. Rinse with wate to remove
    Stop use and ask doctor if rash occurs.
    7.Stop Use : Stop use and ask a doctor if rash occurs
    8.Ask Doctor: Children under 6 months of age: Ask a doctor.
    9.Keep Oot Of Reach Of Children
    : Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
    10.Directions: Apply liberally 15minutes before sun exposure.
    Reapply after 40 minutes of swimming or sweating immediately after towel drying.
    Reapply at least every 2hours.
    11.Other information: Protect the product in this container from excessive heat and direct sun.
    Validity: 3 years
    12.Inactive ingredients: Diisopropyl sebacate, diethylaminohydroxybenzoyl hexyl benzoate, butyl methoxydibenzoylmethane, isononyl isononanoate, diisopropyl adipate, bis-ethylhexyloxyphenol methoxyphenyl triazine , Polyhydroxystearic acid, Cetyl Dimethicone/Hexadecene/Dimethicone, Dimethicone, Cyclopentasiloxane, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-10 Stearate, Polyglyceryl-6 Distearate, Cetearyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer/Polysorbate-60/Sorbitan Isostearate, Xanthan Gum, Methylpropanediol, Glycerin, Water, Potassium Cetyl Phosphate, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol/Decyl Glucoside/Propylene Glycol/Xanthan Gum/Water, Dipropylene Glycol/1,2-Hexanediol/Caprylyl Glycol/Ethylhexylglycerin
    13.Questions: Toll-free number 001 (206)852-4528

  • INGREDIENTS AND APPEARANCE
    VSHELL SUNSCREEN 
    sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84507-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISCOTRIZINOL (UNII: 2UTZ0QC864) (ISCOTRIZINOL - UNII:2UTZ0QC864) ISCOTRIZINOL2 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 100 mL
    TOCOTRIENOLS (UNII: KP2MW85SSQ) (TOCOTRIENOLS - UNII:KP2MW85SSQ) TOCOTRIENOLS1 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 mL
    ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4) ETHYLHEXYL TRIAZONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    WATER (UNII: 059QF0KO0R)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    1-HEXADECENE (UNII: 97T015M2UX)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BISOCTRIZOLE (UNII: 8NT850T0YS)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84507-001-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only07/13/2024
    Labeler - Guangdong Miaolian Cosmetics Co., Ltd. (707598469)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Miaolian Cosmetics Co., Ltd.707598469manufacture(84507-001)