FDA.reportPublic FDA data

ORGANIC ZINCLEAR SUNSCREEN

Manufacturer
ASTIVITA LIMITED
Effective date
2021-07-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:43

Label at a glance#

ProductORGANIC ZINCLEAR SUNSCREEN
Active ingredientZINC OXIDE
Label structure1 sections

Label contents#

Full prescribing information#

Principal Display Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front LabelFront LabelBack LabelBack Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80982-009-362022-07-29C16284748780-1e4f33bdf-a199-d8a0-e053-dadaa90a6e4eOrganic ZinClear Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80982-009-36ORGANIC ZINCLEAR SUNSCREEN94 g in 1 TUBELOTION942

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80982-009ORGANIC ZINCLEAR SUNSCREEN (ZINC OXIDE) LOTION [ASTIVITA LIMITED]2Legacy NDC, 1 package rows20210731_c7aabc17-b8c1-10dd-e053-2995a90ada46.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80982-00980982-009-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALUMINUM OXIDELMI26O6933IACT
MALTODEXTRIN7CVR7L4A2DIACT
CANDELILLA WAXWL0328HX19IACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL724GKU717MIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
c84c6e5e-733c-f00c-e053-2995a90a07c1c7aabc17-b8c1-10dd-e053-2995a90ada462021-07-29Exact identifier
spl id: c84c6e5e-733c-f00c-e053-2995a90a07c1
spl set id: c7aabc17-b8c1-10dd-e053-2995a90ada46

Reported adverse events (FAERS/openFDA)#

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