FDA.reportPublic FDA data

Sunscreen

Manufacturer
Scottsdale Skin Boutique Aesthetics Pllc | Custom Analytics LLC | Fragrance Manufacturing Inc | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:51

Label at a glance#

ProductSunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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-130385331202508GTIN-13: 0385331202508
EAN-13: 0385331202508
GTIN-12: 385331202508
UPC-A: 385331202508
GTIN storage (14 digits): 00385331202508		202 scottsdale.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85331-202-50Sunscreen53 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
85331-20285331-202-50
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
ALUMINALMI26O6933IACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE92RU3N3Y1OIACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT

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
SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique Aesthetics Pllc34a49563-c74b-2fd1-e063-6394a90a6c562025-12-11Exact identifier
ndc (package): 85331-202-50
ndc (product): 85331-202
ndc11 (package): 85331020250
spl id: 45af2200-2af2-0e26-e063-6394a90a0df5
spl set id: 34a49563-c74b-2fd1-e063-6394a90a6c56
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.