FDA.reportPublic FDA data

Non-Tinted Mineral Sunscreen

Manufacturer
R. Sonia Batra, MD, Inc. | 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 01:23:13

Label at a glance#

ProductNon-Tinted Mineral Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC 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-130385359202504GTIN-13: 0385359202504
EAN-13: 0385359202504
GTIN-12: 385359202504
UPC-A: 385359202504
GTIN storage (14 digits): 00385359202504		BATRA 202.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85359-202-50Non-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
85359-20285359-202-50
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
TITANIUM DIOXIDE15FIX9V2JPACTIB
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
ZINC OXIDESOI2LOH54ZACTIB
ALUMINALMI26O6933IACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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 OXIDER. Sonia Batra, MD, Inc.3592edca-cab0-6c44-e063-6294a90a17272025-12-15Exact identifier
ndc (package): 85359-202-50
ndc (product): 85359-202
ndc11 (package): 85359020250
spl id: 4603afe7-83f5-709b-e063-6294a90ab258
spl set id: 3592edca-cab0-6c44-e063-6294a90a1727
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.