MINERAL UV SHIELD SPF30- titanium dioxide and zinc oxide cream 
Omorovicza Kozmetikai Kft.

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.

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Mineral UV Shield SPF30

DRUG FACTS

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.

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
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)

Revised: 8/2014
Document Id: 1551287e-cb70-4833-9c37-5c2d5c0a5bb7
Set id: e6b4cfda-4c5f-4cdd-9c9f-99cb7d28bb3c
Version: 1
Effective Time: 20140805
 
Omorovicza Kozmetikai Kft.