FDA.reportPublic FDA data

Sunscreen

Manufacturer
Private Label Select Ltd CO
Effective date
2020-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:40

Label at a glance#

ProductSunscreen
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

WARNINGS SECTION

Warnings SectionWarnings Section

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

Indications and Usage

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

OTC-Purpose Section

OTC - PURPOSE SECTION

OTC-Purpose SectionOTC-Purpose Section

OTC-Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

OTC-Active ingredient sectionOTC-Active ingredient section

Front Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front LabelFront Label

Back Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Back LabelBack Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62932-218-262022-01-28C16284748780-1d6a99b39-ac63-a426-e053-dadaa90af4c2Suntegrity, Mineral Sun Stick, SPF 30 - Tinted Medium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62932-218-26Sunscreen46 g in 1 TUBEOINTMENT461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62932-218SUNSCREEN (ZINC OXIDE SUNSCREEN) OINTMENT [PRIVATE LABEL SELECT LTD CO]1Legacy NDC, 1 package rows20200717_aa837ee6-7b25-d4d0-e053-2a95a90a6885.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62932-21862932-218-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
.BETA.-TOCOPHEROL9U6A490501IACT
ZINC OXIDESOI2LOH54ZACTIB
CASTOR OILD5340Y2I9GIACT
FERRIC OXYHYDROXIDE87PZU03K0KIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SUNFLOWER OIL3W1JG795YIIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
.GAMMA.-TOCOPHEROL8EF1Z1238FIACT
MICAV8A1AW0880IACT
CARNAUBA WAXR12CBM0EIZIACT
SHEA BUTTERK49155WL9YIACT
ALOE VERA LEAFZY81Z83H0XIACT
.DELTA.-TOCOPHEROLJU84X1II0NIACT
COCOA BUTTER512OYT1CRRIACT
WHITE WAX7G1J5DA97FIACT
CANDELILLA WAXWL0328HX19IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT

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
aa837ee6-7b26-d4d0-e053-2a95a90a6885aa837ee6-7b25-d4d0-e053-2a95a90a68852020-07-15WarningsExact identifier
spl id: aa837ee6-7b26-d4d0-e053-2a95a90a6885
spl set id: aa837ee6-7b25-d4d0-e053-2a95a90a6885

Reported adverse events (FAERS/openFDA)#

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