FDA.reportPublic FDA data

Mineral Sunscreen Moisturizing Non-Tinted

Manufacturer
Cutis Wellness Dermatology And Dermatopathology PLLC | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:04

Label at a glance#

ProductMineral Sunscreen Moisturizing Non-Tinted
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-130385431226503GTIN-13: 0385431226503
EAN-13: 0385431226503
GTIN-12: 385431226503
UPC-A: 385431226503
GTIN storage (14 digits): 00385431226503		cutis wellness 226.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85431-226-50Mineral Sunscreen Moisturizing Non-Tinted50 g in 1 BOTTLE, PUMPCREAM502

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85431-22685431-226-50
58892-226

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
ZINC OXIDESOI2LOH54ZACTIB
CYCLOHEXASILOXANEXHK3U310BAIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CERAMIDE 34370DF050BIACT
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
Mineral Sunscreen Moisturizing Non-TintedZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC3360a208-5f17-a74b-e063-6294a90a13e12025-12-09Exact identifier
ndc (package): 85431-226-50
ndc (product): 85431-226
ndc11 (package): 85431022650
spl id: 45870e47-7775-4eb8-e063-6394a90a7ec3
spl set id: 3360a208-5f17-a74b-e063-6294a90a13e1
Proceuticals Private Label by TiZO non-tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd2203ea22-d12a-99fe-e063-6394a90aca9f2024-09-13WarningsExact identifier
ndc (product): 58892-226

Reported adverse events (FAERS/openFDA)#

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