FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Manufacturer
Maloney Plastic Surgery Skin Care, PLLC | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:20:57

Label at a glance#

ProductTinted Mineral Sunscreen
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-130385318203504GTIN-13: 0385318203504
EAN-13: 0385318203504
GTIN-12: 385318203504
UPC-A: 385318203504
GTIN storage (14 digits): 00385318203504		Maloney Tinted Mineral Sunscreen 203.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85318-203-50Tinted 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 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85318-20385318-203-50
58892-203

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

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 OXIDEMaloney Plastic Surgery Skin Care, PLLC316b7584-c782-fe9e-e063-6394a90a76fe2025-12-09Exact identifier
ndc (package): 85318-203-50
ndc (product): 85318-203
ndc11 (package): 85318020350
spl id: 45875797-5d3c-491e-e063-6294a90aed5d
spl set id: 316b7584-c782-fe9e-e063-6394a90a76fe
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
ndc (product): 58892-203

Reported adverse events (FAERS/openFDA)#

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