FDA.reportPublic FDA data

Advanced Formula Tinted

Manufacturer
CR KEEFE ENTERPRISES, INC. | 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 01:23:33

Label at a glance#

ProductAdvanced Formula Tinted
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-130385883203152GTIN-13: 0385883203152
EAN-13: 0385883203152
GTIN-12: 385883203152
UPC-A: 385883203152
GTIN storage (14 digits): 00385883203152		char sf 203.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85883-203-15Advanced Formula Tinted1.5 g in 1 PACKETCREAM1.52

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
85883-20385883-203-15
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
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CI 77492EX438O2MRTIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CI 77499XM0M87F357IACT
CI 774911K09F3G675IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
ZINC OXIDESOI2LOH54ZACTIB
ALUMINALMI26O6933IACT

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
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984c4b7-94ee-2a8e-e063-6294a90ac24f2025-12-15Exact identifier
ndc (package): 85883-203-15
ndc (product): 85883-203
ndc11 (package): 85883020315
spl id: 46040c81-0042-0811-e063-6294a90a5a84
spl set id: 3984c4b7-94ee-2a8e-e063-6294a90ac24f
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984920a-feb9-169c-e063-6394a90a95682025-12-15Exact identifier
ndc (product): 85883-203
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.