FDA.reportPublic FDA data

Complexion Enhancer SPF15

Manufacturer
Omorovicza Kozmetikai Kft.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:57

Label at a glance#

ProductComplexion Enhancer SPF15
Active ingredientTitanium dioxide, Zinc oxide
Label structure7 sections

Indications and uses

Protects from UVA/B sunrays

Dosage and administration

Apply evenly to face and neck.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTSPURPOSE
Titanium Dioxide 1.5%Sunscreen
Zinc Oxide 3.2%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

Apply evenly to face and neck.

INGREDIENTS

INACTIVE INGREDIENT SECTION

Aqua (Hungarian Thermal Water), Caprylic/Capric Triglyceride, Zinc Oxide, Squalane, Cetearyl Ethylhexanoate, Glycerin, Corundum (Pro Ruby Crystal), Stearyl Heptanoate, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Titanium Dioxide, Butyrospermum Parkii (Shea) Butter, Prunus Armeniaca (Apricot) Kernel Oil, Phenoxyethanol, Ethylhexylglycerin, Galactoarabinan, Lactic Acid, Pyrus Malus, Pectin, Chlorella Vulgaris/Lupinus Albus Protein Ferment, Parfum (Fragrance), Geraniol, Citronellol, Linalool, Malpighia Punicifolia (Acerola) Fruit Extract, Zinc gluconate, Magnesium aspartate, Copper gluconate, Mannitol, Yeast Extract, Hydrolyzed Soy Protein, Mica, Silica, Xanthan Gum, Tocopherol (Vitamin E), Disodium EDTA, CI 77492/ CI 77491/ CI 77499 (Iron Oxides)

PRINCIPAL DISPLAY PANEL - 50ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPLEXION ENHANCER
SPF 15
ARCTÓNUS JAVITÓ

Omorovicza
BUDAPEST

e 1.7 fl oz    50ml

Principal Display Panel - 50ml Bottle Carton
Principal Display Panel - 50ml Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41442-110-012019-10-29C16284748780-1960f7f55-cb2d-8e05-e053-dbdaa90a074aComplexion Enhancer SPF15
41442-110-022019-10-29C16284748780-1960f7f55-cb2d-8e05-e053-dbdaa90a074aComplexion Enhancer SPF15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41442-110-01Complexion Enhancer SPF151 in 1 BOXCREAM11
41442-110-01Complexion Enhancer SPF1550 mL in 1 BOTTLE, GLASSCREAM501
41442-110-02Complexion Enhancer SPF15125 mL in 1 BOTTLE, PUMPCREAM1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41442-110COMPLEXION ENHANCER SPF15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT.]1Legacy NDC, 3 package rows20110510_2a7edfb9-4d01-4d37-a5e1-99acbba68a44.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium dioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc oxideACTIVE INGREDIENTSOI2LOH54Z1
Titanium dioxideACTIVE MOIETY15FIX9V2JP1
Zinc oxideACTIVE MOIETYSOI2LOH54Z1
.BETA.-CITRONELLOL, (+/-)-INACTIVE INGREDIENT565OK72VNF1
AcerolaINACTIVE INGREDIENTXDD2WEC9L51
Alpha-TocopherolINACTIVE INGREDIENTH4N855PNZ11
Aluminum OxideINACTIVE INGREDIENTLMI26O69331
AppleINACTIVE INGREDIENTB423VGH5S91
Apricot Seed OilINACTIVE INGREDIENT54JB35T06A1
Caprylic/Capric Mono/DiglyceridesINACTIVE INGREDIENTU72Q2I8C851
Cetearyl EthylhexanoateINACTIVE INGREDIENT9M64UO4C251
Cetearyl OlivateINACTIVE INGREDIENT58B69Q84JO1
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1S1
Copper GluconateINACTIVE INGREDIENTRV823G6G671
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
EthylhexylglycerinINACTIVE INGREDIENT147D247K3P1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F3571
GeraniolINACTIVE INGREDIENTL837108USY1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Lactic AcidINACTIVE INGREDIENT33X04XA5AT1
LINALOOL, (+)-INACTIVE INGREDIENTF4VNO44C091
Magnesium AspartateINACTIVE INGREDIENTR17X820ROL1
MannitolINACTIVE INGREDIENT3OWL53L36A1
MicaINACTIVE INGREDIENTV8A1AW08801
PectinINACTIVE INGREDIENT89NA02M4RX1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Shea ButterINACTIVE INGREDIENTK49155WL9Y1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU41
Sorbitan OlivateINACTIVE INGREDIENTMDL271E3GR1
Soy ProteinINACTIVE INGREDIENTR44IWB3RN51
SqualaneINACTIVE INGREDIENTGW89575KF91
Stearyl HeptanoateINACTIVE INGREDIENT2M4UGL1NCN1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1
YeastINACTIVE INGREDIENT3NY3SM6B8U1
Zinc GluconateINACTIVE INGREDIENTU6WSN5SQ1Z1

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41442-11041442-110-01, 41442-110-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium dioxide15FIX9V2JPACTIB
Zinc oxideSOI2LOH54ZACTIB
Caprylic/Capric Mono/DiglyceridesU72Q2I8C85IACT
SqualaneGW89575KF9IACT
Cetearyl Ethylhexanoate9M64UO4C25IACT
GlycerinPDC6A3C0OXIACT
Aluminum OxideLMI26O6933IACT
Stearyl Heptanoate2M4UGL1NCNIACT
Cetostearyl Alcohol2DMT128M1SIACT
Cetearyl Olivate58B69Q84JOIACT
Sorbitan OlivateMDL271E3GRIACT
Shea ButterK49155WL9YIACT
Apricot Seed Oil54JB35T06AIACT
PhenoxyethanolHIE492ZZ3TIACT
Ethylhexylglycerin147D247K3PIACT
Lactic Acid33X04XA5ATIACT
AppleB423VGH5S9IACT
Pectin89NA02M4RXIACT
GeraniolL837108USYIACT
.BETA.-CITRONELLOL, (+/-)-565OK72VNFIACT
LINALOOL, (+)-F4VNO44C09IACT
AcerolaXDD2WEC9L5IACT
Zinc GluconateU6WSN5SQ1ZIACT
Magnesium AspartateR17X820ROLIACT
Copper GluconateRV823G6G67IACT
Mannitol3OWL53L36AIACT
Yeast3NY3SM6B8UIACT
Soy ProteinR44IWB3RN5IACT
MicaV8A1AW0880IACT
Silicon DioxideETJ7Z6XBU4IACT
Xanthan GumTTV12P4NEEIACT
Alpha-TocopherolH4N855PNZ1IACT
Edetate Disodium7FLD91C86KIACT
Ferrosoferric OxideXM0M87F357IACT

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 7 · 364 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AGUM, CHEWING / BUCCAL891 mgExact identifier — unii candidate
65 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ALOZENGE / ORAL20546 mgExact identifier — unii candidate
65 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBMUCOSAL2.94 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATAEROSOL, FOAM / TOPICAL11 mgExact identifier — unii candidate
18 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / SUBLINGUAL10.25 mgExact identifier — unii candidate
65 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS19 mgExact identifier — unii candidate
77 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii candidate
77 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASOLUTION/ DROPS / OPHTHALMIC4.6 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATCONCENTRATE / ORAL50 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii candidate
49 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
MannitolMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / ORAL7093 mgExact identifier — unii candidate
65 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATCAPSULE / ORAL132 mgExact identifier — unii candidate
18 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SqualaneSQUALANEGW89575KF9SOLUTION / TOPICAL1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MannitolMANNITOL3OWL53L36APOWDER, FOR SOLUTION / ORAL3767 mgExact identifier — unii candidate
65 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ACAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
65 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASOLUTION, GEL FORMING / DROPS / OPHTHALMIC4 mgExact identifier — unii candidate
65 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATINJECTION, SOLUTION / INTRAVENOUS87 mgExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATLOTION / TOPICAL5.7 %w/wExact identifier — unii candidate
18 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
33b6c804-5246-4826-8e76-6d9b636948c32a7edfb9-4d01-4d37-a5e1-99acbba68a442011-03-01WarningsExact identifier
spl id: 33b6c804-5246-4826-8e76-6d9b636948c3
spl set id: 2a7edfb9-4d01-4d37-a5e1-99acbba68a44

Reported adverse events (FAERS/openFDA)#

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