FDA.reportPublic FDA data

SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR

Manufacturer
SHISEIDO AMERICA INC.
Effective date
2019-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:11

Label at a glance#

ProductSHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 1
Active ingredientENSULIZOLE, OCTINOXATE, TITANIUM DIOXIDE
Label structure12 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: lim...

Storage and handling

protect this product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTS:Purpose
ENSULIZOLE 2.0%Sunscreen
OCTINOXATE 7.4%Sunscreen
TITANIUM DIOXIDE 7.2%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, DIMETHICONE, SD ALCOHOL 40-B, PENTAERYTHRITYL TETRAETHYLHEXANOATE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYMETHYL METHACRYLATE, GLYCERIN, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, HYDROGENATED POLYDECENE, TRIMETHYLSILOXYSILICATE, SILICA, XYLITOL, PEG-6, PEG-32, PEG/PPG-14/7 DIMETHYL ETHER, THIOTAURINE, SAXIFRAGA SARMENTOSA EXTRACT, ARGININE HCl, ONONIS SPINOSA ROOT EXTRACT, SODIUM PCA, SOPHORA ANGUSTIFOLIA ROOT EXTRACT, PPG-17, ALUMINUM HYDROXIDE, AMINOMETHYL PROPANOL, ALUMINUM DISTEARATE, ISOSTEARIC ACID, STEARIC ACID, TRISODIUM EDTA, POLYMETHYLSILSESQUIOXANE, TALC, BUTYLENE GLYCOL, ALCOHOL, ALUMINA, POLYSILICONE-2, TRIETHOXYCAPRYLYLSILANE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES, TITANIUM DIOXIDE,

Other information

STORAGE AND HANDLING SECTION

  • protect this product in this container from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022

SHISEIDO DIST.
NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

1

Anti-Aging
UV Care

43

Urban Environment
Tinted UV Protector

BROAD SPECTRUM
SPF 43

For Face
OIL-FREE

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

30mL NET WT. 1.1OZ.

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton
PRINCIPAL DISPLAY PANEL - 30mL Tube Carton

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

2

Anti-Aging
UV Care

43

Urban Environment
Tinted UV Protector

BROAD SPECTRUM
SPF 43

For Face
OIL-FREE

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

30mL NET WT. 1.1OZ.

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton
PRINCIPAL DISPLAY PANEL - 30mL Tube Carton

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

3

Anti-Aging
UV Care

43

Urban Environment
Tinted UV Protector

BROAD SPECTRUM
SPF 43

For Face
OIL-FREE

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

30mL NET WT. 1.1OZ.

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton
PRINCIPAL DISPLAY PANEL - 30mL Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-339-602024-01-30C16284748780-11030e365-5394-111a-e063-dadaa90a10e2SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR
52686-340-602024-01-30C16284748780-11030e365-5394-111a-e063-dadaa90a10e2SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR
52686-341-602024-01-30C16284748780-11030e365-5394-111a-e063-dadaa90a10e2SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52686-339-60SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 132.79 g in 1 TUBECREAM32.792
52686-339-60SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 11 in 1 CARTONCREAM12
52686-340-60SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 21 in 1 CARTONCREAM12
52686-340-60SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 232.79 g in 1 TUBECREAM32.792
52686-341-60SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 332.79 g in 1 TUBECREAM32.792
52686-341-60SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 31 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52686-339SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 1 (ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE) CREAM SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 2 (ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE) CREAM SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 3 (ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE) CREAM [SHISEIDO AMERICA INC.]2Legacy NDC, 2 package rows20191221_51e55ec8-b9f3-4475-b34f-e4eb6e46491b.zip
52686-340SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 1 (ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE) CREAM SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 2 (ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE) CREAM SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 3 (ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE) CREAM [SHISEIDO AMERICA INC.]2Legacy NDC, 2 package rows20191221_51e55ec8-b9f3-4475-b34f-e4eb6e46491b.zip
52686-341SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 1 (ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE) CREAM SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 2 (ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE) CREAM SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 3 (ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE) CREAM [SHISEIDO AMERICA INC.]2Legacy NDC, 2 package rows20191221_51e55ec8-b9f3-4475-b34f-e4eb6e46491b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W421
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ENSULIZOLEACTIVE MOIETY9YQ9DI1W421
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALUMINUM DISTEARATEINACTIVE INGREDIENT7P1HP1B9UI1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN01
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q1
ARGININE HYDROCHLORIDEINACTIVE INGREDIENTF7LTH1E20Y1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MB1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB71
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00621
ONONIS SPINOSA ROOTINACTIVE INGREDIENTFD2FMC53M11
PEG/PPG-14/7 DIMETHYL ETHERINACTIVE INGREDIENT6DNW9T7YT21
PENTAERYTHRITYL TETRAETHYLHEXANOATEINACTIVE INGREDIENTXJ7052W8971
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33A1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQ1
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)INACTIVE INGREDIENT59Z907ZB691
PPG-17INACTIVE INGREDIENTOV0Q322E0U1
SAXIFRAGA STOLONIFERA LEAFINACTIVE INGREDIENTO3TMV4903H1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A21
SOPHORA FLAVESCENS ROOTINACTIVE INGREDIENTIYR6K8KQ5K1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
SYZYGIUM JAMBOS LEAFINACTIVE INGREDIENT407Z4W5LFF1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
THIOTAURINEINACTIVE INGREDIENTNQZ2D7AO621
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)INACTIVE INGREDIENT5041RX63GN1
WATERINACTIVE INGREDIENT059QF0KO0R1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52686-33952686-339-60
52686-34052686-340-60
52686-34152686-341-60

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 120 matching rows.

Name, UNII, Kind table
NameUNIIKind
ENSULIZOLE9YQ9DI1W42ACTIB
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
PENTAERYTHRITYL TETRAETHYLHEXANOATEXJ7052W897IACT
GLYCERINPDC6A3C0OXIACT
DIPROPYLENE GLYCOLE107L85C40IACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XYLITOLVCQ006KQ1EIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
THIOTAURINENQZ2D7AO62IACT
SAXIFRAGA STOLONIFERA LEAFO3TMV4903HIACT
ARGININE HYDROCHLORIDEF7LTH1E20YIACT
ONONIS SPINOSA ROOTFD2FMC53M1IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
PPG-17OV0Q322E0UIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALUMINUM DISTEARATE7P1HP1B9UIIACT
ISOSTEARIC ACIDX33R8U0062IACT
STEARIC ACID4ELV7Z65APIACT
EDETATE TRISODIUM420IP921MBIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
TALC7SEV7J4R1UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALCOHOL3K9958V90MIACT
ALUMINUM OXIDELMI26O6933IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SYZYGIUM JAMBOS LEAF407Z4W5LFFIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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 8 · 422 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
20 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQOINTMENT / TOPICAL1114 mgExact identifier — unii candidate
13 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FOR SUSPENSION / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, FOR SUSPENSION / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION, EXTENDED RELEASE / ORAL46 mgExact identifier — unii candidate
35 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii candidate
12 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KFILM, SOLUBLE / ORAL0.06 mgExact identifier — unii candidate
32 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSWAB / TOPICAL0.5 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675DROPS / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED / ORAL87 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii candidate
12 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33ATABLET, COATED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS44.22 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQCREAM / TOPICAL20 mgExact identifier — unii candidate
13 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii candidate
40 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 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
022697e2-73c5-4b8e-86e9-f891cccca4bb51e55ec8-b9f3-4475-b34f-e4eb6e46491b2019-12-20WarningsExact identifier
spl id: 022697e2-73c5-4b8e-86e9-f891cccca4bb
spl set id: 51e55ec8-b9f3-4475-b34f-e4eb6e46491b

Reported adverse events (FAERS/openFDA)#

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