SUNKISS  SPF15- 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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SUNKISS
SPF 15
NAPVARÁZS

Drug Facts

ACTIVE INGREDIENTSPURPOSE
Titanium Dioxide 1.35%Sunscreen
Zinc Oxide 6%Sunscreen

USES

Protects from UVA/B sunrays.

WARNING

For external use only; do not swallow.

Stop use if rash or irritation occurs.

DIRECTIONS

Appy evenly to face and neck.

INGREDIENTS

Aqua (Hungarian Thermal Water), Caprylic/Capric Triglyceride, Zinc Oxide, Glycerin, Squalane, Titanium Dioxide, Corundum (Pro Ruby Crystal), Cetearyl Ethylhexanoate, Cetearyl Olivate, Sorbitan Olivate, Stearyl Heptanoate, Cetearyl Alcohol, Saccharomyces Ferment Extract, Phenoxyethanol, Polyhydroxystearic Acid, Isostearic Acid, Mica, Parfum (Fragrance), Geraniol, Citronellol, Linalool, Prunus Armeniaca (Apricot) Kernel Oil, Chlorella Vulgaris/Lupinus Albus Protein Ferment, Malpighia Punicifolia (Acerola) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Pectin, Phospholipids, Tocopherol, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin, Lactic Acid, Galactoarabinan, Isopropyl Titanium Triisostearate, CI 77492/ CI 77491/ CI 77499 (Iron Oxides).

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

PRINCIPAL DISPLAY PANEL - 50ml Bottle Carton

SUNKISS
SPF 15
NAPVARÁZS

Omorovicza
BUDAPEST

e 1.7 fl oz    50ml

Principal Display Panel - 50ml Bottle Carton
SUNKISS   SPF15
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41442-133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP) titanium dioxide0.675 mL  in 50 mL
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide3 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
glycerin (UNII: PDC6A3C0OX)  
squalane (UNII: GW89575KF9)  
aluminum oxide (UNII: LMI26O6933)  
sorbitan olivate (UNII: MDL271E3GR)  
STEARYL ETHYLHEXANOATE (UNII: X8707A2274)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
isostearic acid (UNII: X33R8U0062)  
mica (UNII: V8A1AW0880)  
geraniol (UNII: L837108USY)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
linalool, dl- (UNII: D81QY6I88E)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
acerola (UNII: XDD2WEC9L5)  
apple (UNII: B423VGH5S9)  
pectin (UNII: 89NA02M4RX)  
alpha-tocopherol (UNII: H4N855PNZ1)  
Edetate Disodium (UNII: 7FLD91C86K)  
xanthan gum (UNII: TTV12P4NEE)  
ethylhexylglycerin (UNII: 147D247K3P)  
lactic acid (UNII: 33X04XA5AT)  
ferric oxide red (UNII: 1K09F3G675)  
ferric oxide yellow (UNII: EX438O2MRT)  
ferrosoferric oxide (UNII: XM0M87F357)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41442-133-011 in 1 BOX
150 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/06/2011
Labeler - Omorovicza Kozmetikai Kft (525432105)
Establishment
NameAddressID/FEIBusiness Operations
Omorovicza Kozmetikai Kft525432105LABEL, MANUFACTURE

Revised: 5/2011
Document Id: 99c23df0-8293-412b-b9a6-3b72fadc024a
Set id: 5523eaee-0879-4932-85e3-bd878d1498f6
Version: 1
Effective Time: 20110506
 
Omorovicza Kozmetikai Kft