FDA.reportPublic FDA data

Defend Tinted Mineral SPF 40

Manufacturer
SMOOTH ESTHETICS LLC | 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 01:21:58

Label at a glance#

ProductDefend Tinted Mineral SPF 40
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-130385603203509GTIN-13: 0385603203509
EAN-13: 0385603203509
GTIN-12: 385603203509
UPC-A: 385603203509
GTIN storage (14 digits): 00385603203509		smooth 203.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85603-203-50Defend Tinted Mineral SPF 4053 g in 1 BOTTLE, PUMPCREAM532

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85603-20385603-203-50
58892-203

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
CI 77499XM0M87F357IACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CI 77492EX438O2MRTIACT
ALUMINALMI26O6933IACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
CI 774911K09F3G675IACT

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
Defend Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDESMOOTH ESTHETICS LLC36eb9fc0-25d7-cfb4-e063-6394a90a2e222025-12-11Exact identifier
ndc (package): 85603-203-50
ndc (product): 85603-203
ndc11 (package): 85603020350
spl id: 45b122ec-8050-2cf2-e063-6294a90a18a4
spl set id: 36eb9fc0-25d7-cfb4-e063-6394a90a2e22
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
ndc (product): 58892-203

Reported adverse events (FAERS/openFDA)#

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