Sunkiss

Manufacturer: Omorovicza Kozmetikai Kft
Effective date: 2011-05-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:27:58

Label at a glance#

ProductSunkiss SPF15

Active ingredienttitanium dioxide, zinc oxide

Label structure8 sections

Indications and uses

Protects from UVA/B sunrays.

Dosage and administration

Appy evenly to face and neck.

Contacts and useful links#

Websitewww.omorovicza.com

www.omorovicza.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTS	PURPOSE
Titanium Dioxide 1.35%	Sunscreen
Zinc Oxide 6%	Sunscreen

USES

INDICATIONS & USAGE SECTION

Protects from UVA/B sunrays.

WARNING

WARNINGS SECTION

For external use only; do not swallow.

OTC - STOP USE SECTION

Stop use if rash or irritation occurs.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Appy evenly to face and neck.

INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNKISS
SPF 15
NAPVARÁZS

Omorovicza
BUDAPEST

e 1.7 fl oz 50ml

Principal Display Panel - 50ml Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41442-133-01	2019-10-29	C162847	48780-1	960f7f55-c6d7-8e05-e053-dbdaa90a074a	SUNKISS SPF 15 NAPVARÁZS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41442-133-01	Sunkiss SPF15	1 in 1 BOX	CREAM	1		1
41442-133-01	Sunkiss SPF15	50 mL in 1 BOTTLE, GLASS	CREAM	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41442-133	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1	Legacy NDC, 2 package rows	20110510_5523eaee-0879-4932-85e3-bd878d1498f6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
titanium dioxide	ACTIVE INGREDIENT	15FIX9V2JP	1
zinc oxide	ACTIVE INGREDIENT	SOI2LOH54Z	1
titanium dioxide	ACTIVE MOIETY	15FIX9V2JP	1
zinc oxide	ACTIVE MOIETY	SOI2LOH54Z	1
.BETA.-CITRONELLOL, (R)-	INACTIVE INGREDIENT	P01OUT964K	1
acerola	INACTIVE INGREDIENT	XDD2WEC9L5	1
alpha-tocopherol	INACTIVE INGREDIENT	H4N855PNZ1	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
apple	INACTIVE INGREDIENT	B423VGH5S9	1
APRICOT KERNEL OIL	INACTIVE INGREDIENT	54JB35T06A	1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES	INACTIVE INGREDIENT	U72Q2I8C85	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	1
geraniol	INACTIVE INGREDIENT	L837108USY	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
HYDROXYSTEARIC ACID	INACTIVE INGREDIENT	933ANU3H2S	1
isostearic acid	INACTIVE INGREDIENT	X33R8U0062	1
lactic acid	INACTIVE INGREDIENT	33X04XA5AT	1
linalool, dl-	INACTIVE INGREDIENT	D81QY6I88E	1
mica	INACTIVE INGREDIENT	V8A1AW0880	1
pectin	INACTIVE INGREDIENT	89NA02M4RX	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
sorbitan olivate	INACTIVE INGREDIENT	MDL271E3GR	1
squalane	INACTIVE INGREDIENT	GW89575KF9	1
STEARYL ETHYLHEXANOATE	INACTIVE INGREDIENT	X8707A2274	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

Sunkiss SPF15
titanium dioxide and zinc oxide
titanium dioxide
zinc oxide
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES
glycerin
squalane
aluminum oxide
sorbitan olivate
STEARYL ETHYLHEXANOATE
cetostearyl alcohol
PHENOXYETHANOL
HYDROXYSTEARIC ACID
isostearic acid
mica
geraniol
.BETA.-CITRONELLOL, (R)-
linalool, dl-
APRICOT KERNEL OIL
acerola
apple
pectin
alpha-tocopherol
Edetate Disodium
xanthan gum
ethylhexylglycerin
lactic acid
ferric oxide red
ferric oxide yellow
ferrosoferric oxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41442-133	41442-133-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
titanium dioxide	15FIX9V2JP	ACTIB
zinc oxide	SOI2LOH54Z	ACTIB
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES	U72Q2I8C85	IACT
glycerin	PDC6A3C0OX	IACT
squalane	GW89575KF9	IACT
aluminum oxide	LMI26O6933	IACT
sorbitan olivate	MDL271E3GR	IACT
STEARYL ETHYLHEXANOATE	X8707A2274	IACT
cetostearyl alcohol	2DMT128M1S	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
HYDROXYSTEARIC ACID	933ANU3H2S	IACT
isostearic acid	X33R8U0062	IACT
mica	V8A1AW0880	IACT
geraniol	L837108USY	IACT
.BETA.-CITRONELLOL, (R)-	P01OUT964K	IACT
linalool, dl-	D81QY6I88E	IACT
APRICOT KERNEL OIL	54JB35T06A	IACT
acerola	XDD2WEC9L5	IACT
apple	B423VGH5S9	IACT
pectin	89NA02M4RX	IACT
alpha-tocopherol	H4N855PNZ1	IACT
Edetate Disodium	7FLD91C86K	IACT
xanthan gum	TTV12P4NEE	IACT
ethylhexylglycerin	147D247K3P	IACT
lactic acid	33X04XA5AT	IACT
ferric oxide red	1K09F3G675	IACT
ferric oxide yellow	EX438O2MRT	IACT
ferrosoferric oxide	XM0M87F357	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 293 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
lactic acid	LACTIC ACID	33X04XA5AT	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	INJECTION / SUBCUTANEOUS		10 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
alpha-tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	SOLUTION / ORAL	1.05 mg/1ml		Exact identifier — unii candidate 10 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	INJECTION, SOLUTION / INTRAVENOUS		87 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / ORAL		24 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
squalane	SQUALANE	GW89575KF9	SOLUTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
cetostearyl alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	SOLUTION / TOPICAL	7.22 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii candidate 18 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	INJECTION / INTRAVENOUS		2232 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	SUSPENSION / TOPICAL	0.7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
squalane	SQUALANE	GW89575KF9	CREAM / TOPICAL	6 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	SUSPENSION, EXTENDED RELEASE / ORAL	2.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
alpha-tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	FILM, SOLUBLE / BUCCAL	0.07 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	INJECTION / INTRACARDIAC	0.01 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ferrosoferric oxide	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES	GLYCERYL MONO- AND DICAPRYLOCAPRATE	U72Q2I8C85	CAPSULE / ORAL		13770 mg	Exact identifier — unii candidate 3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
99c23df0-8293-412b-b9a6-3b72fadc024a			5523eaee-0879-4932-85e3-bd878d1498f6	2011-05-06	Warnings	Exact identifier spl id: 99c23df0-8293-412b-b9a6-3b72fadc024a spl set id: 5523eaee-0879-4932-85e3-bd878d1498f6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.