FDA.reportPublic FDA data

Melan RX

Manufacturer
Melan RX
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:42:45

Label at a glance#

ProductMelan RX
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Melan RX

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Melan RX

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Melan RX

INDICATIONS & USAGE SECTION

Indications & usageIndications & usage

Melan RX

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Melan RX

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

Melan RX

OTC - PURPOSE SECTION

purposepurpose

Melan RX

WARNINGS SECTION

Warning LabelWarning Label

Melan RX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82635-403-01Melan RX45 mL in 1 BOTTLELOTION455

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
82635-40382635-403-01

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
ZINC OXIDESOI2LOH54ZACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
LAURYL PEG-8 DIMETHICONE (300 CPS)ELL2U7K8T8IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ALLANTOIN344S277G0ZIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM CHLORIDE451W47IQ8XIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
CAPRYLYL GLYCOL00YIU5438UIACT
FERRIC OXIDE RED1K09F3G675IACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)9KB5R958PBIACT
PROPANEDIOL5965N8W85TIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.BETA.-TOCOPHEROL9U6A490501IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
TRILAURETH-4 PHOSPHATEM96W2OLL2VIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
ISODODECANEA8289P68Y2IACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-08-21full-release2026-06-01 01:11:25

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
Melan RXZINC OXIDEMelan RXf4bdf20c-b6bc-55f1-e053-2995a90ac3082025-11-06WarningsExact identifier
ndc (package): 82635-403-01
ndc (product): 82635-403
ndc11 (package): 82635040301
spl id: 42f3c4f9-335e-595e-e063-6294a90a20f0
spl set id: f4bdf20c-b6bc-55f1-e053-2995a90ac308

Reported adverse events (FAERS/openFDA)#

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