FDA.reportPublic FDA data

Sunsolve MD Calm and Revitalize

Manufacturer
Sunsolve MD Inc
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:16:01

Label at a glance#

ProductSunsolve MD Calm and Revitalize
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Sunsolve MD Calm and Revitalize

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Sunsolve MD Calm and Revitalize

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Sunsolve MD Calm and Revitalize

INDICATIONS & USAGE SECTION

Indications & usageIndications & usage

Sunsolve MD Calm and Revitalize

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Sunsolve MD Calm and Revitalize

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

Sunsolve MD Calm and Revitalize

OTC - PURPOSE SECTION

purposepurpose

Sunsolve MD Calm and Revitalize

WARNINGS SECTION

Warning LabelWarning Label

Sunsolve MD Calm and Revitalize

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-135061023120040GTIN-13: 5061023120040
EAN-13: 5061023120040
GTIN storage (14 digits): 05061023120040		Sunsolve_MD_Calm Revitalize_AW_v14_Page_1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84878-654-01Sunsolve MD Calm and Revitalize48 mL in 1 BOTTLE, PUMPLOTION484
84878-654-02Sunsolve MD Calm and Revitalize1 in 1 CARTONLOTION14

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84878-65484878-654-01, 84878-654-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENYLPROPANOL0F897O3O4MIACT
XANTHAN GUMTTV12P4NEEIACT
ISOAMYL LAURATEM1SLX00M3MIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
TOCOPHEROLR0ZB2556P8IACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETETH-20I835H2IHHXIACT
PULLULAN8ZQ0AYU1TTIACT
SQUALANEGW89575KF9IACT
STEARETH-20L0Q8IK9E08IACT
ZINC OXIDESOI2LOH54ZACTIB
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALLANTOIN344S277G0ZIACT
PEG-75 STEARATEOT38R0N74HIACT
GLYCERYL STEARATE230OU9XXE4IACT
SCLEROTIUM GUM2X51AD1X3TIACT
AVENA SATIVA (OAT) KERNEL OIL3UVP41R77RIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
SODIUM HYDROXIDE55X04QC32IIACT
PYRUS MALUS (APPLE) FRUITB423VGH5S9IACT

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
Sunsolve MD Calm and RevitalizeZINC OXIDESunsolve MD Inc26f3f534-a305-3530-e063-6394a90a75e12025-11-14WarningsExact identifier
ndc (package): 84878-654-02
ndc (package): 84878-654-01
ndc (product): 84878-654
ndc11 (package): 84878065402
ndc11 (package): 84878065401
spl id: 43923d19-4229-a579-e063-6294a90a87b9
spl set id: 26f3f534-a305-3530-e063-6394a90a75e1

Reported adverse events (FAERS/openFDA)#

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