FDA.reportPublic FDA data

Odacite Color Balm

Manufacturer
Odacite
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:39:39

Label at a glance#

ProductOdacite Color Balm
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Odacite Color Balm

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Odacite Color Balm

INACTIVE INGREDIENT SECTION

Inactive IngredientInactive Ingredient

Odacite Color Balm

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

Odacite Color Balm

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

Odacite Color Balm

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

Odacite Color Balm

OTC - PURPOSE SECTION

PurposePurpose

Odacite Color Balm

WARNINGS SECTION

WarningWarning

Odacite Color Balm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82088-25082088-250-01, 82088-250-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIB
ISOHEXADECANE918X1OUF1EIACT
TIN OXIDEKM7N50LOS6IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MICAV8A1AW0880IACT
ISODODECANEA8289P68Y2IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
C13-15 ALKANE114P5I43UJIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
FERRIC OXIDE RED1K09F3G675IACT
CALCIUM SODIUM BOROSILICATE4MM76N4WMYIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-08-14full-release2026-06-01 01:10:34

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
52bae89c-3f1f-5c7e-e063-6294a90afbaa3c565aed-3fde-b5d3-e063-6294a90af7002026-05-26WarningsExact identifier
spl set id: 3c565aed-3fde-b5d3-e063-6294a90af700

Reported adverse events (FAERS/openFDA)#

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