FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Manufacturer
Gentlehomme LLC | Custom Analytics LLC | Fragrance Manufacturing INC | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:25:35

Label at a glance#

ProductTinted Mineral Sunscreen
Active ingredientZINC 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-130850030774286GTIN-13: 0850030774286
EAN-13: 0850030774286
GTIN-12: 850030774286
UPC-A: 850030774286
GTIN storage (14 digits): 00850030774286		GENTLE 204.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85366-204-60Tinted Mineral Sunscreen60 g in 1 BOTTLE, PUMPCREAM602

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85366-20485366-204-60
58892-204

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
CI 77499XM0M87F357IACT
ZINC OXIDESOI2LOH54ZACTIB
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
WATER059QF0KO0RIACT
CI 77492EX438O2MRTIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
SODIUM CHLORIDE451W47IQ8XIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
CI 774911K09F3G675IACT
MICAV8A1AW0880IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
TRIETHANOLAMINE9O3K93S3TKIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYSORBATE 207T1F30V5YHIACT

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 SunscreenZINC OXIDEGentlehomme LLC365e7d8e-e3e0-4c08-e063-6294a90af4152025-12-16Exact identifier
ndc (package): 85366-204-60
ndc (product): 85366-204
ndc11 (package): 85366020460
spl id: 4614bcf0-8d3d-d59f-e063-6294a90ad265
spl set id: 365e7d8e-e3e0-4c08-e063-6294a90af415
Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxideZINC OXIDEFallien Cosmeceuticals, Ltd1dda8259-4121-3c76-e063-6394a90af1892024-07-22WarningsExact identifier
ndc (product): 58892-204

Reported adverse events (FAERS/openFDA)#

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