FDA.reportPublic FDA data

Duette Untinted

Manufacturer
Skin Theory Studios
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:42:33

Label at a glance#

ProductDuette Untinted
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Duette Untinted

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Duette Untinted

INACTIVE INGREDIENT SECTION

Inactive IngredientInactive Ingredient

Duette Untinted

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

Duette Untinted

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

Duette Untinted

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

Duette Untinted

OTC - PURPOSE SECTION

PurposePurpose

Duette Untinted

WARNINGS SECTION

WarningWarning

Duette Untinted

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84123-2033-1Duette Untinted30 mL in 1 BOTTLELOTION302
84123-2033-2Duette Untinted1 in 1 CARTONLOTION12

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84123-203384123-2033-1, 84123-2033-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
NIACINAMIDE25X51I8RD4IACT
PROPANEDIOL5965N8W85TIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE687U3PEB2YIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
WATER059QF0KO0RIACT
JOJOBA OIL724GKU717MIACT
ORYZA SATIVA WHOLE84IVV0906ZIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TOCOPHEROLR0ZB2556P8IACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCO-CAPRYLATE4828G836N6IACT
NYLON-12446U8J075BIACT
PHENYLPROPANOL0F897O3O4MIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
METHYLPROPANEDIOLN8F53B3R4RIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
ALLANTOIN344S277G0ZIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ROSMARINUS OFFICINALIS FLOWERNR1A27F29OIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
ZINC OXIDESOI2LOH54ZACTIB
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-08-21full-release2026-06-01 01:11:20

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
Duette UntintedZINC OXIDESkin Theory Studios3ce24b39-8bb1-1246-e063-6294a90a32d42025-11-06WarningsExact identifier
ndc (package): 84123-2033-1
ndc (package): 84123-2033-2
ndc (product): 84123-2033
ndc11 (package): 84123203302
ndc11 (package): 84123203301
spl id: 42f36d14-0bfe-66e5-e063-6394a90a515b
spl set id: 3ce24b39-8bb1-1246-e063-6294a90a32d4

Reported adverse events (FAERS/openFDA)#

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