Label: MINERAL UV SHIELD SPF30- titanium dioxide and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 August 5, 2014

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTSPURPOSE
    Titanium Dioxide 1.5%Sunscreen
    Zinc Oxide 8.6%Sunscreen
  • USES

    Protects from UVA/B sunrays

  • WARNING

    For external use only; do not swallow.

    Stop use if rash or irritation occurs.

    Keep out of reach for children.

    When using this product keep out of eyes.

  • DIRECTIONS

    Apply evenly to face and neck. Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating or immediately after towel drying or at least every 2 hours.

  • INGREDIENTS

    Aqua (Hungarian Thermal Water), Caprylic/Capric Triglyceride, Zinc Oxide, Silica, Squalane, Glycerin, Ethylhexyldodecanol, Stearyl Heptanoate, Cetearyl Olivate, Cetearyl Ethylhexanoate, Titanium Dioxide, Sorbitan Olivate, Phenoxyethanol, Ascorbyl Tetraisopalmitate, Cetearyl Alcohol, Saccharomyces (Hungarian Thermal Water) Ferment Extract, Polyhydroxystearic Acid, Disodium EDTA, Alumina, Sodium Hyaluronate, Parfum (Fragrance), Prunus Armeniaca (Apricot) Kernel Oil, Tocopherol, Ethylhexylglycerin, Isostearic Acid, Lactic Acid, Xanthan Gum, Phospholipids, Linalool, Limonene, Citral.

  • SPL UNCLASSIFIED SECTION

    Product of Hungary
    www.omorovicza.com
    Omorovicza Kft, 2 Andrassy Ut, 1061 Budapest

  • PRINCIPAL DISPLAY PANEL - 100 ml Tube Box

    MINERAL UV SHIELD
    SPF 30

    Omorovicza
    BUDAPEST

    e 3.4 fl oz 100ml

    PRINCIPAL DISPLAY PANEL - 100 ml Tube Box
  • INGREDIENTS AND APPEARANCE
    MINERAL UV SHIELD SPF30 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41442-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide15 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide86 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Squalane (UNII: GW89575KF9)  
    Glycerin (UNII: PDC6A3C0OX)  
    Stearyl Heptanoate (UNII: 2M4UGL1NCN)  
    Cetearyl Olivate (UNII: 58B69Q84JO)  
    Cetearyl Ethylhexanoate (UNII: 9M64UO4C25)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Apricot Kernel Oil (UNII: 54JB35T06A)  
    Tocopherol (UNII: R0ZB2556P8)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Isostearic Acid (UNII: X33R8U0062)  
    Lactic Acid (UNII: 33X04XA5AT)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Omega-3 Fatty Acids (UNII: 71M78END5S)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    Citral (UNII: T7EU0O9VPP)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41442-152-011 in 1 BOX
    1100 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/01/2015
    Labeler - Omorovicza Kozmetikai Kft. (525432105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Omorovicza Kozmetikai Kft.525432105LABEL(41442-152) , MANUFACTURE(41442-152)
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