SUNKISS- titanium dioxide and zinc oxide cream

Sunkiss by

Drug Labeling and Warnings

Sunkiss by is a Otc medication manufactured, distributed, or labeled by Omorovicza Kozmetikai Kft. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• ACTIVE INGREDIENTS: PURPOSE
• 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).

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

SUNKISS   SPF15
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41442-133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP)	titanium dioxide	0.675 mL  in 50 mL
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	3 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41442-133-01	1 in 1 BOX
1		50 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/06/2011

Labeler - Omorovicza Kozmetikai Kft (525432105)

Establishment
Name	Address	ID/FEI	Business Operations
Omorovicza Kozmetikai Kft		525432105	LABEL, MANUFACTURE