FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Manufacturer
LEILANI VIDAL | Custom Analytics LLC | Fragrance Manufacturing INC | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:57

Label at a glance#

ProductTinted Mineral Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
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-130385645258505GTIN-13: 0385645258505
EAN-13: 0385645258505
GTIN-12: 385645258505
UPC-A: 385645258505
GTIN storage (14 digits): 00385645258505		Lash 258.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85645-258-50Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

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
85645-25885645-258-50
58892-258

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CI 774911K09F3G675IACT
MICAV8A1AW0880IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
ZINC OXIDESOI2LOH54ZACTIB
CI 77499XM0M87F357IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYLHEXYL HYDROXYSTEARATE BENZOATE3W8F25684BIACT
CI 77492EX438O2MRTIACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
ISODODECANEA8289P68Y2IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ISOHEXADECANE918X1OUF1EIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
SODIUM CHLORIDE451W47IQ8XIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
TOCOPHEROLR0ZB2556P8IACT
TRIETHANOLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CETEARETH-20YRC528SWUYIACT

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
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEILANI VIDAL36d5831a-7128-729a-e063-6394a90a80362025-12-11Exact identifier
ndc (package): 85645-258-50
ndc (product): 85645-258
ndc11 (package): 85645025850
spl id: 45b40fc7-3e8b-cacf-e063-6294a90a8251
spl set id: 36d5831a-7128-729a-e063-6394a90a8036
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
ndc (product): 58892-258

Reported adverse events (FAERS/openFDA)#

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