FDA.reportPublic FDA data

non-tinted mineral sunscreen

Manufacturer
Skin & Bare It LLC | 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 01:21:37

Label at a glance#

Productnon-tinted mineral sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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-130385425202506GTIN-13: 0385425202506
EAN-13: 0385425202506
GTIN-12: 385425202506
UPC-A: 385425202506
GTIN storage (14 digits): 00385425202506		BARE 202.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85425-202-50non-tinted mineral sunscreen53 g in 1 BOTTLE, PUMPCREAM532

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
85425-20285425-202-50
58892-202

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINALMI26O6933IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT

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
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDESkin & Bare It LLC35d3ef95-621c-f193-e063-6294a90ac3ee2025-12-10Exact identifier
ndc (package): 85425-202-50
ndc (product): 85425-202
ndc11 (package): 85425020250
spl id: 459b23c1-d687-e47c-e063-6294a90a102e
spl set id: 35d3ef95-621c-f193-e063-6294a90ac3ee
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1ce8c1da-565d-5487-e063-6294a90a1bde2024-07-10WarningsExact identifier
ndc (product): 58892-202

Reported adverse events (FAERS/openFDA)#

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