FDA.reportPublic FDA data

ODACITE

Manufacturer
Odacite Skincare
Effective date
2023-03-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:23

Label at a glance#

ProductODACITE
Active ingredientZINC OXIDE
Label structure1 sections

Label contents#

Full prescribing information#

Odacite

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82088-131-022025-01-30C16284748780-12cef2736-7c34-d83d-e063-dadaa90ab31fODACITE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82088-131-01ODACITE30 mL in 1 BOTTLE, PUMPLOTION302
82088-131-02ODACITE1 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82088-131ODACITE (ZINC OXIDE) LOTION [ODACITE SKINCARE]2Legacy NDC, 2 package rows20230308_dcf17c10-291b-3e59-e053-2a95a90a87db.zip

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
82088-13182088-131-01, 82088-131-02

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
NameUNIIKind
JOJOBA OIL724GKU717MIACT
GLYCERINPDC6A3C0OXIACT
ORYZA SATIVA WHOLE84IVV0906ZIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TOCOPHEROLR0ZB2556P8IACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCO-CAPRYLATE4828G836N6IACT
NYLON-12446U8J075BIACT
PHENYLPROPANOL0F897O3O4MIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
METHYLHEPTYL ISOSTEARATE981F40Q9FFIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
ALLANTOIN344S277G0ZIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ROSMARINUS OFFICINALIS FLOWERNR1A27F29OIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
ZINC OXIDESOI2LOH54ZACTIB
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
PROPANEDIOL5965N8W85TIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE687U3PEB2YIACT
CHAMOMILEFGL3685T2XIACT

Source Document#

Source XML

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
f6546ed6-4ac3-44da-e053-2995a90a8401dcf17c10-291b-3e59-e053-2a95a90a87db2023-03-07Exact identifier
spl id: f6546ed6-4ac3-44da-e053-2995a90a8401
spl set id: dcf17c10-291b-3e59-e053-2a95a90a87db

Reported adverse events (FAERS/openFDA)#

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