FDA.reportPublic FDA data

20Percent Zinc Oxide Non Tinted

Manufacturer
JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 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 01:25:51

Label at a glance#

Product20Percent Zinc Oxide Non Tinted
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-130385585205041GTIN-13: 0385585205041
EAN-13: 0385585205041
GTIN-12: 385585205041
UPC-A: 385585205041
GTIN storage (14 digits): 00385585205041		roth 205.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85585-205-0420Percent Zinc Oxide Non Tinted113 g in 1 BOTTLE, PUMPCREAM1132

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85585-20585585-205-04
58892-205

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

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

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
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c108f6-a928-0a54-e063-6394a90ae6862025-12-16Exact identifier
ndc (product): 85585-205
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0ccca-c993-181e-e063-6294a90a7ae62025-12-16Exact identifier
ndc (package): 85585-205-04
ndc (product): 85585-205
ndc11 (package): 85585020504
spl id: 46161e86-1ee8-56d5-e063-6294a90af7b3
spl set id: 36c0ccca-c993-181e-e063-6294a90a7ae6
Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxideZINC OXIDEFallien Cosmeceuticals, Ltd1bbd14ec-4240-f0c2-e063-6394a90a2c072024-06-25WarningsExact identifier
ndc (product): 58892-205

Reported adverse events (FAERS/openFDA)#

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