FDA.reportPublic FDA data

Indie Lee Daily Primer

Manufacturer
America Exchange
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#

ProductIndie Lee Daily Primer
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Indie Lee Daily Primer

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Indie Lee Daily Primer

INACTIVE INGREDIENT SECTION

Inactive IngredientInactive Ingredient

Indie Lee Daily Primer

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

Indie Lee Daily Primer

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

Indie Lee Daily Primer

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

Indie Lee Daily Primer

OTC - PURPOSE SECTION

PurposePurpose

Indie Lee Daily Primer

WARNINGS SECTION

WarningWarning

Indie Lee Daily Primer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78870-245-01Indie Lee Daily Primer40 mL in 1 BOTTLE, DROPPERLOTION402
78870-245-02Indie Lee Daily Primer1 in 1 CARTONLOTION12

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78870-24578870-245-01, 78870-245-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
ROSMARINUS OFFICINALIS FLOWERNR1A27F29OIACT
ZINC OXIDESOI2LOH54ZACTIB
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE687U3PEB2YIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
ORYZA SATIVA WHOLE84IVV0906ZIACT
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
NYLON-12446U8J075BIACT
COCO-CAPRYLATE4828G836N6IACT
HYDROLYZED JOJOBA ESTERSUDR641JW8WIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PROPANEDIOL5965N8W85TIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ALLANTOIN344S277G0ZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TOCOPHEROLR0ZB2556P8IACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENYLPROPANOL0F897O3O4MIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-07-01full-release2026-06-01 01:08:06

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
Indie Lee Daily PrimerZINC OXIDEAmerica Exchange38e5232b-7daf-7e61-e063-6394a90aa5b02025-11-06WarningsExact identifier
ndc (package): 78870-245-02
ndc (package): 78870-245-01
ndc (product): 78870-245
ndc11 (package): 78870024501
ndc11 (package): 78870024502
spl id: 42f33ef4-cb23-83b1-e063-6294a90aeb21
spl set id: 38e5232b-7daf-7e61-e063-6394a90aa5b0

Reported adverse events (FAERS/openFDA)#

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