FDA.reportPublic FDA data

Mineral UV Shield SPF30

Manufacturer
Omorovicza Kozmetikai Kft.
Effective date
2014-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:15

Label at a glance#

ProductMineral UV Shield SPF30
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure8 sections

Indications and uses

Protects from UVA/B sunrays

Dosage and administration

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.

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 8.6%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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach for children.

OTC - WHEN USING SECTION

When using this product keep out of eyes.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 100 ml Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MINERAL UV SHIELD
SPF 30

Omorovicza
BUDAPEST

e 3.4 fl oz 100ml

PRINCIPAL DISPLAY PANEL - 100 ml Tube Box
PRINCIPAL DISPLAY PANEL - 100 ml Tube Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41442-152-012019-11-27C16284748780-19855e2a2-498c-60a7-e053-dbdaa90a05bdMineral UV Shield SPF30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41442-152-01Mineral UV Shield SPF30100 mL in 1 TUBECREAM1001
41442-152-01Mineral UV Shield SPF301 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41442-152MINERAL UV SHIELD SPF30 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT.]1Legacy NDC, 2 package rows20150101_e6b4cfda-4c5f-4cdd-9c9f-99cb7d28bb3c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
Aluminum OxideINACTIVE INGREDIENTLMI26O69331
Apricot Kernel OilINACTIVE INGREDIENT54JB35T06A1
Ascorbyl TetraisopalmitateINACTIVE INGREDIENT47143LT58A1
Cetearyl EthylhexanoateINACTIVE INGREDIENT9M64UO4C251
Cetearyl OlivateINACTIVE INGREDIENT58B69Q84JO1
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1S1
CitralINACTIVE INGREDIENTT7EU0O9VPP1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
EthylhexylglycerinINACTIVE INGREDIENT147D247K3P1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Hyaluronate SodiumINACTIVE INGREDIENTYSE9PPT4TH1
Isostearic AcidINACTIVE INGREDIENTX33R8U00621
Lactic AcidINACTIVE INGREDIENT33X04XA5AT1
Linalool, (+/-)-INACTIVE INGREDIENTD81QY6I88E1
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7U1
Omega-3 Fatty AcidsINACTIVE INGREDIENT71M78END5S1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Polyhydroxystearic Acid (2300 MW)INACTIVE INGREDIENTYXH47AOU0F1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU41
Sorbitan OlivateINACTIVE INGREDIENTMDL271E3GR1
SqualaneINACTIVE INGREDIENTGW89575KF91
Stearyl HeptanoateINACTIVE INGREDIENT2M4UGL1NCN1
TocopherolINACTIVE INGREDIENTR0ZB2556P81
WaterINACTIVE INGREDIENT059QF0KO0R1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41442-15241442-152-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Silicon DioxideETJ7Z6XBU4IACT
SqualaneGW89575KF9IACT
GlycerinPDC6A3C0OXIACT
Stearyl Heptanoate2M4UGL1NCNIACT
Cetearyl Olivate58B69Q84JOIACT
Cetearyl Ethylhexanoate9M64UO4C25IACT
Sorbitan OlivateMDL271E3GRIACT
PhenoxyethanolHIE492ZZ3TIACT
Ascorbyl Tetraisopalmitate47143LT58AIACT
Cetostearyl Alcohol2DMT128M1SIACT
Polyhydroxystearic Acid (2300 MW)YXH47AOU0FIACT
Edetate Disodium7FLD91C86KIACT
Aluminum OxideLMI26O6933IACT
Hyaluronate SodiumYSE9PPT4THIACT
Apricot Kernel Oil54JB35T06AIACT
TocopherolR0ZB2556P8IACT
Ethylhexylglycerin147D247K3PIACT
Isostearic AcidX33R8U0062IACT
Lactic Acid33X04XA5ATIACT
Xanthan GumTTV12P4NEEIACT
Omega-3 Fatty Acids71M78END5SIACT
Linalool, (+/-)-D81QY6I88EIACT
CitralT7EU0O9VPPIACT

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 6 · 301 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATAEROSOL, FOAM / TOPICAL11 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii candidate
9 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATTABLET / ORALADJ PHExact identifier — unii candidate
18 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
Isostearic AcidISOSTEARIC ACIDX33R8U0062OINTMENT / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATCAPSULE / ORAL132 mgExact identifier — unii candidate
18 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATINJECTION / INTRACARDIAC0.01 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATCONCENTRATE / ORAL50 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
Aluminum OxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
TocopherolTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRABURSAL0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 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
1551287e-cb70-4833-9c37-5c2d5c0a5bb7e6b4cfda-4c5f-4cdd-9c9f-99cb7d28bb3c2014-08-05WarningsExact identifier
spl id: 1551287e-cb70-4833-9c37-5c2d5c0a5bb7
spl set id: e6b4cfda-4c5f-4cdd-9c9f-99cb7d28bb3c

Reported adverse events (FAERS/openFDA)#

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