FDA.reportPublic FDA data

CLE DE PEAU BEAUTE GENTLE PROTECTIVE I

Manufacturer
SHISEIDO CO., LTD.
Effective date
2012-09-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:45:21

Label at a glance#

ProductCLE DE PEAU BEAUTE GENTLE PROTECTIVE I
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE
Label structure10 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 use a water resistant sunscreen if swimming or sweating reapply 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 su...

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
AVOBENZONE 2.5%Sunscreen
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 2.0%Sunscreen
OXYBENZONE 1.0%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

For external use only

OTC - DO NOT USE SECTION

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
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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, ALCOHOL, DIPROPYLENE GLYCOL, GLYCERIN, HYDROGENATED POLYDECENE, XYLITOL, DIMETHICONE, ISODODECANE, TRIETHYLHEXANOIN, PEG-5 GLYCERYL STEARATE, ISOSTEARIC ACID, SILICA, DIPHENYLSILOXY PHENYL TRIMETHICONE, XANTHAN GUM, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, TOCOPHERYL ACETATE, GLYCYL GLYCINE, CRATAEGUS MONOGYNA FLOWER EXTRACT, SERINE, 2-O-ETHYL ASCORBIC ACID, SODIUM ACETYLATED HYALURONATE, POLYQUATERNIUM-51, SAXIFRAGA SARMENTOSA EXTRACT, UNCARIA GAMBIR EXTRACT, GINKGO BILOBA LEAF EXTRACT, ROSA ROXBURGHII FRUIT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, HYPERICUM ERECTUM EXTRACT, HYDROLYZED SILK, BUPLEURUM FALCATUM ROOT EXTRACT, COIX LACRYMA-JOBI MA-YUEN SEED EXTRACT, PPG-17, TRIETHANOLAMINE, GLYCERYL STEARATE SE, BEHENIC ACID, STEARIC ACID, BEHENYL ALCOHOL, BATYL ALCOHOL, PEG-30 SOY STEROL, CARBOMER, DISODIUM EDTA, CELLULOSE GUM, SODIUM METAPHOSPHATE, BUTYLENE GLYCOL, BHT, SODIUM MAGNESIUM SILICATE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE,

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

Manufactured by
SHISEIDO CO., LTD.
7-5-5 GINZA TOKYO

PRINCIPAL DISPLAY PANEL - 125mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

gentle protective emulsion

BROAD SPECTRUM
SPF 22
SUNSCREEN

125mL 4.2 FL. OZ.

Principal Display Panel - 125mL Bottle Carton
Principal Display Panel - 125mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52685-462-102023-09-25C16284748780-197449f38-b648-f6ea-e053-dbdaa90aa703CLE DE PEAU BEAUTE GENTLE PROTECTIVE I
52685-462-102019-11-13C16284748780-197449f38-b648-f6ea-e053-dbdaa90aa703CLE DE PEAU BEAUTE GENTLE PROTECTIVE I

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW81
2-O-ETHYL ASCORBIC ACIDINACTIVE INGREDIENT801M14RK9K1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
BATILOLINACTIVE INGREDIENT39YR661C4U1
BEHENIC ACIDINACTIVE INGREDIENTH390488X0A1
BUPLEURUM FALCATUM ROOTINACTIVE INGREDIENTX04E310LUY1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3111
COIX LACRYMA-JOBI VAR. MA-YUEN SEEDINACTIVE INGREDIENT8DW238I7ZI1
CRATAEGUS MONOGYNA FLOWERINACTIVE INGREDIENTNT52AMP29J1
DIGLYCINEINACTIVE INGREDIENT10525P22U01
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIPHENYLSILOXY PHENYL TRIMETHICONEINACTIVE INGREDIENTI445L28B121
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GINKGOINACTIVE INGREDIENT19FUJ2C58T1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB71
ISODODECANEINACTIVE INGREDIENTA8289P68Y21
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00621
PEG-5 GLYCERYL STEARATEINACTIVE INGREDIENT8CAC4NQ8721
PEG/PPG-17/4 DIMETHYL ETHERINACTIVE INGREDIENT4ET18WJG5K1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 4:1)INACTIVE INGREDIENTX8Q92E1CPM1
PPG-17INACTIVE INGREDIENTOV0Q322E0U1
ROSA ROXBURGHII FRUITINACTIVE INGREDIENTCVT1AA87FF1
SAXIFRAGA STOLONIFERA LEAFINACTIVE INGREDIENTO3TMV4903H1
SERINEINACTIVE INGREDIENT452VLY94021
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95L1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TRIETHYLHEXANOININACTIVE INGREDIENT7K3W1BIU6K1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52685-46252685-462-10

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
ISODODECANEA8289P68Y2IACT
DIMETHICONE92RU3N3Y1OIACT
XYLITOLVCQ006KQ1EIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
PEG-5 GLYCERYL STEARATE8CAC4NQ872IACT
ISOSTEARIC ACIDX33R8U0062IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
PPG-17OV0Q322E0UIACT
TROLAMINE9O3K93S3TKIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BEHENIC ACIDH390488X0AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
DOCOSANOL9G1OE216XYIACT
BATILOL39YR661C4UIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM7FLD91C86KIACT
PEG/PPG-17/4 DIMETHYL ETHER4ET18WJG5KIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
DIGLYCINE10525P22U0IACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CRATAEGUS MONOGYNA FLOWERNT52AMP29JIACT
SERINE452VLY9402IACT
2-O-ETHYL ASCORBIC ACID801M14RK9KIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 4:1)X8Q92E1CPMIACT
SAXIFRAGA STOLONIFERA LEAFO3TMV4903HIACT

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 · 478 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / ORAL3480 mgExact identifier — unii candidate
44 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESPRAY / SUBLINGUAL22 mgExact identifier — unii candidate
12 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact 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
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KOINTMENT / TOPICAL57 mgExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, EXTENDED RELEASE / ORAL0.03 mgExact identifier — unii candidate
32 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CREAM / VAGINAL0.75 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8AEROSOL, FOAM / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRA-ARTICULAR25 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRA-ARTICULAR0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4GRANULE, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 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
311ca585-af73-4093-8774-4de4b3602aba961e5ed2-81ef-4c65-b000-e1203c2eb6672023-09-25WarningsExact identifier
spl set id: 961e5ed2-81ef-4c65-b000-e1203c2eb667

Reported adverse events (FAERS/openFDA)#

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