FDA.reportPublic FDA data

Healthy Mineral Sunscreen Face and Body

Manufacturer
Zen Dermatology, Inc. | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:20:58

Label at a glance#

ProductHealthy Mineral Sunscreen Face and Body
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-130385338205045GTIN-13: 0385338205045
EAN-13: 0385338205045
GTIN-12: 385338205045
UPC-A: 385338205045
GTIN storage (14 digits): 00385338205045		Zen Derm Healthy Mineral Sunscreen Face and Body 205.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85338-205-04Healthy Mineral Sunscreen Face and Body113 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
85338-20585338-205-04
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
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
TRIETHANOLAMINE9O3K93S3TKIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
DIMETHICONE92RU3N3Y1OIACT

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
Healthy Mineral Sunscreen Face and BodyZINC OXIDEZen Dermatology, Inc.31e376b4-098f-34d7-e063-6394a90a17722025-12-08Exact identifier
ndc (package): 85338-205-04
ndc (product): 85338-205
ndc11 (package): 85338020504
spl id: 45761429-5d0b-9ac7-e063-6394a90a073c
spl set id: 31e376b4-098f-34d7-e063-6394a90a1772
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.