FDA.reportPublic FDA data

Non Tinted Mineral Sunscreen

Manufacturer
SPECKTRA6 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 01:22:02

Label at a glance#

ProductNon Tinted Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85395-205-04Non Tinted Mineral Sunscreen113 g in 1 BOTTLE, PUMPCREAM1132

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85395-20585395-205-04
58892-205

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
POLYSORBATE 207T1F30V5YHIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
DIMETHICONE92RU3N3Y1OIACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
SODIUM CHLORIDE451W47IQ8XIACT
TRIETHANOLAMINE9O3K93S3TKIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non Tinted Mineral SunscreenZINC OXIDESPECKTRA6 LLC374e1c8e-5c5c-9198-e063-6294a90a3b882025-12-11Exact identifier
ndc (product): 85395-205
Non Tinted Mineral SunscreenZINC OXIDESPECKTRA6 LLC374f063a-1ea6-2fcc-e063-6394a90ac5742025-12-11Exact identifier
ndc (package): 85395-205-04
ndc (product): 85395-205
ndc11 (package): 85395020504
spl id: 45b0e810-9832-c30c-e063-6294a90a6019
spl set id: 374f063a-1ea6-2fcc-e063-6394a90ac574
Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxideZINC OXIDEFallien Cosmeceuticals, Ltd1bbd14ec-4240-f0c2-e063-6394a90a2c072024-06-25WarningsExact identifier
ndc (product): 58892-205

Reported adverse events (FAERS/openFDA)#

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