FDA.reportPublic FDA data

Tinted Mineral Matte CE Sunscreen

Manufacturer
The Maui Medical Group, Inc | 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 01:21:52

Label at a glance#

ProductTinted Mineral Matte CE Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85394-203-15Tinted Mineral Matte CE Sunscreen15 g in 1 PACKETCREAM152

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
85394-20385394-203-15
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
CI 774911K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CI 77492EX438O2MRTIACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
ALUMINALMI26O6933IACT
ZINC OXIDESOI2LOH54ZACTIB
CYCLOHEXASILOXANEXHK3U310BAIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
CI 77499XM0M87F357IACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b72d14-b69b-e9dd-e063-6394a90a748e2025-12-11Exact identifier
ndc (package): 85394-203-15
ndc (product): 85394-203
ndc11 (package): 85394020315
spl id: 45b375fc-1b1e-17d8-e063-6394a90adedc
spl set id: 34b72d14-b69b-e9dd-e063-6394a90a748e
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b60880-5fe1-b78f-e063-6294a90a748d2025-12-11Exact identifier
ndc (product): 85394-203
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.