FDA.reportPublic FDA data

Mineral Primer tinted SPF40

Manufacturer
Oracle Esthetics, LLC | Custom Analytics LLC | Fragrance Manufacturing INC | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:23:10

Label at a glance#

ProductMineral Primer tinted SPF40
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385356201852GTIN-13: 0385356201852
EAN-13: 0385356201852
GTIN-12: 385356201852
UPC-A: 385356201852
GTIN storage (14 digits): 00385356201852		Oracle 201.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85356-201-85Mineral Primer tinted SPF4085 g in 1 BOTTLE, PUMPCREAM852

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85356-20185356-201-85
58892-201

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CI 774911K09F3G675IACT
CI 77492EX438O2MRTIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DIMETHICONE92RU3N3Y1OIACT
ZINC OXIDESOI2LOH54ZACTIB
ALUMINALMI26O6933IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CI 77499XM0M87F357IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
ndc (package): 85356-201-85
ndc (product): 85356-201
ndc11 (package): 85356020185
spl id: 46001ae9-9f4d-7837-e063-6394a90a6bdf
spl set id: 3542d8d3-35a3-7d63-e063-6394a90a6fd1
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
ndc (product): 58892-201

Reported adverse events (FAERS/openFDA)#

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