FDA.reportPublic FDA data

Non-Tinted 20% Zinc Mineral Sunscreen

Manufacturer
BELLA MEDICAL SKIN CARE | 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 01:23:23

Label at a glance#

ProductNon-Tinted 20% Zinc Mineral Sunscreen
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-130385758205151GTIN-13: 0385758205151
EAN-13: 0385758205151
GTIN-12: 385758205151
UPC-A: 385758205151
GTIN storage (14 digits): 00385758205151		SF205 cellicon skin.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85758-205-15Non-Tinted 20% Zinc Mineral Sunscreen15 g in 1 PACKETCREAM152

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
85758-20585758-205-15
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
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
SODIUM CHLORIDE451W47IQ8XIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHANOLAMINE9O3K93S3TKIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
ZINC OXIDESOI2LOH54ZACTIB
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYSORBATE 207T1F30V5YHIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36d9d83b-7da5-a006-e063-6394a90a9d842025-12-15Exact identifier
ndc (product): 85758-205
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36da1a55-c076-cdd9-e063-6294a90ac97c2025-12-15Exact identifier
ndc (package): 85758-205-15
ndc (product): 85758-205
ndc11 (package): 85758020515
spl id: 4603db8e-2443-c231-e063-6294a90a31bf
spl set id: 36da1a55-c076-cdd9-e063-6294a90ac97c
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.