FDA.reportPublic FDA data

Prime And Protect Dewy

Manufacturer
Kalon Skin Studio, LLC | 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#

ProductPrime And Protect Dewy
Active ingredientZINC 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-130385363204600GTIN-13: 0385363204600
EAN-13: 0385363204600
GTIN-12: 385363204600
UPC-A: 385363204600
GTIN storage (14 digits): 00385363204600		KALON 204.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85363-204-60Prime And Protect Dewy60 g in 1 BOTTLE, PUMPCREAM602

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85363-20485363-204-60
58892-204

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
MICAV8A1AW0880IACT
ZINC OXIDESOI2LOH54ZACTIB
BISMUTH OXYCHLORIDE4ZR792I587IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
CI 77492EX438O2MRTIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
CI 77499XM0M87F357IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERINPDC6A3C0OXIACT
CI 774911K09F3G675IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TRIETHANOLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POLYSORBATE 207T1F30V5YHIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT

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
Prime And Protect DewyZINC OXIDEKalon Skin Studio, LLC3593cefe-a08f-eb88-e063-6394a90aaff62025-12-15Exact identifier
ndc (package): 85363-204-60
ndc (product): 85363-204
ndc11 (package): 85363020460
spl id: 4603d0f3-a854-95bc-e063-6394a90a9a7f
spl set id: 3593cefe-a08f-eb88-e063-6394a90aaff6
Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxideZINC OXIDEFallien Cosmeceuticals, Ltd1dda8259-4121-3c76-e063-6394a90af1892024-07-22WarningsExact identifier
ndc (product): 58892-204

Reported adverse events (FAERS/openFDA)#

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