FDA.reportPublic FDA data

Baby Mineral SPF 50

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2021-02-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:53

Label at a glance#

ProductBaby Mineral SPF 50
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsActive ingredients

DOSAGE & ADMINISTRATION SECTION

Dose & AdministrationDose & Administration

OTC - PURPOSE SECTION

PurposePurpose

WARNINGS SECTION

WarningsWarnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

INDICATIONS & USAGE SECTION

Indication & UseIndication & Use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-0437-42024-01-30C16284748780-1ba0f9c33-354c-a910-e053-dadaa90a0b85AL00437 Baby Mineral SPF 50+
61995-0437-42021-02-05C16284748780-1ba0f9c33-354c-a910-e053-dadaa90a0b85AL00437 Baby Mineral SPF 50+
61995-0437-42021-01-29C16284748780-1ba0f9c33-354c-a910-e053-dadaa90a0b85AL00437 Baby Mineral SPF 50+

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-0437-4Baby Mineral SPF 50113 g in 1 TUBELOTION1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-0437BABY MINERAL SPF 50 (ZINC OXIDE 17.0%) LOTION [THE HAIN CELESTIAL GROUP, INC.]2Legacy NDC, 1 package rows20210207_9974b40d-2596-2a0e-e053-2a95a90a9246.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-043761995-0437-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
JUNIPERUS VIRGINIANA OILPAD4FN7P2GIACT
O-ANISALDEHYDE7CP821WF2WIACT
CETEARYL OLIVATE58B69Q84JOIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LEVULINATEVK44E1MQU8IACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
SHEA BUTTERK49155WL9YIACT
CARNAUBA WAXR12CBM0EIZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SODIUM ANISATEF9WFJ28MV9IACT
VANILLINCHI530446XIACT
.BETA.-CITRONELLOL, (+/-)-565OK72VNFIACT
ALCOHOL3K9958V90MIACT
LINALOOL, (+/-)-D81QY6I88EIACT
GERANIOLL837108USYIACT
SORBITAN OLIVATEMDL271E3GRIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
ORANGE OILAKN3KSD11BIACT
CHAMOMILEFGL3685T2XIACT
BENZYL ACETATE0ECG3V79ZJIACT
C10-18 TRIGLYCERIDES43AGM4PHPIIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
POLYGLYCERYL-2 SESQUIOLEATERHP7Q83BVBIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
COCONUT ALKANES1E5KJY107TIACT
ALOE VERA LEAFZY81Z83H0XIACT
MICAV8A1AW0880IACT
GLYCERINPDC6A3C0OXIACT
LIMONENE, (+/-)-9MC3I34447IACT
ZINC OXIDESOI2LOH54ZACTIB

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
ba9f6ffe-e3c2-b48c-e053-2995a90a69289974b40d-2596-2a0e-e053-2a95a90a92462021-02-05WarningsExact identifier
spl id: ba9f6ffe-e3c2-b48c-e053-2995a90a6928
spl set id: 9974b40d-2596-2a0e-e053-2a95a90a9246

Reported adverse events (FAERS/openFDA)#

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