FDA.reportPublic FDA data

ProtectME Tinted Mineral SPF 40 20%

Manufacturer
PUREFECTION LA, INC. | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:36

Label at a glance#

ProductProtectME Tinted Mineral SPF 40 20%
Active ingredientZINC OXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385470204609GTIN-13: 0385470204609
EAN-13: 0385470204609
GTIN-12: 385470204609
UPC-A: 385470204609
GTIN storage (14 digits): 00385470204609		PurefectionLA 204.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85470-204-60ProtectME Tinted Mineral SPF 40 20%60 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
85470-20485470-204-60
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
GLYCERINPDC6A3C0OXIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
TRIETHANOLAMINE9O3K93S3TKIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CI 77499XM0M87F357IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
MICAV8A1AW0880IACT
POLYSORBATE 207T1F30V5YHIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
CI 774911K09F3G675IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM CHLORIDE451W47IQ8XIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OIACT
CI 77492EX438O2MRTIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT

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
ProtectME Tinted Mineral SPF 40 20%ZINC OXIDEPUREFECTION LA, INC.33dd1afa-25a8-891f-e063-6294a90a8c8a2025-12-10Exact identifier
ndc (package): 85470-204-60
ndc (product): 85470-204
ndc11 (package): 85470020460
spl id: 459b0d29-8bd5-ae40-e063-6294a90a23bd
spl set id: 33dd1afa-25a8-891f-e063-6294a90a8c8a
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.