FDA.reportPublic FDA data

Odacite Color Balm - Sienna Rose

Manufacturer
Odacite
Effective date
2026-05-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:52

Label at a glance#

ProductOdacite Color Balm - Sienna Rose
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Odacite Color Balm - Sienna Rose

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Odacite Color Balm - Sienna Rose

INACTIVE INGREDIENT SECTION

Inactive IngredientInactive Ingredient

Odacite Color Balm - Sienna Rose

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

Odacite Color Balm - Sienna Rose

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

Odacite Color Balm - Sienna Rose

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

Odacite Color Balm - Sienna Rose

OTC - PURPOSE SECTION

PurposePurpose

Odacite Color Balm - Sienna Rose

WARNINGS SECTION

WarningWarning

Odacite Color Balm - Sienna Rose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82088-499-01Odacite Color Balm - Sienna Rose5 mL in 1 JARLOTION51
82088-499-02Odacite Color Balm - Sienna Rose1 in 1 CARTONLOTION11

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82088-49982088-499-01, 82088-499-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM DIMYRISTATEJ2KA067N9OIACT
CITRIC ACID2968PHW8QPIACT
PHENYLPROPANOL0F897O3O4MIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TOCOPHEROLR0ZB2556P8IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
ZINC OXIDESOI2LOH54ZACTIB
ISOHEXADECANE918X1OUF1EIACT
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
PROPANEDIOL5965N8W85TIACT
CAPRYLYL GLYCOL00YIU5438UIACT

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
Odacite Color Balm - Sienna RoseZINC OXIDEOdacite52ba7f12-2b79-79cf-e063-6294a90a92d82026-05-26WarningsExact identifier
ndc (package): 82088-499-01
ndc (package): 82088-499-02
ndc (product): 82088-499
ndc11 (package): 82088049901
ndc11 (package): 82088049902
spl id: 52ba9432-0ca2-31e4-e063-6394a90a63e2
spl set id: 52ba7f12-2b79-79cf-e063-6294a90a92d8

Reported adverse events (FAERS/openFDA)#

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