FDA.reportPublic FDA data

Ultimate Physical Sunscreen

Manufacturer
HALEM DERMATOLOGY 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 01:21:56

Label at a glance#

ProductUltimate Physical Sunscreen
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-130385413205137GTIN-13: 0385413205137
EAN-13: 0385413205137
GTIN-12: 385413205137
UPC-A: 385413205137
GTIN storage (14 digits): 00385413205137		HALEM 205 KIDS.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85413-205-13Ultimate Physical 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
85413-20585413-205-13
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
CAPRYLYL GLYCOL00YIU5438UIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
TRIETHANOLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
POLYSORBATE 207T1F30V5YHIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ZINC OXIDESOI2LOH54ZACTIB
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT

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
Ultimate Physical SunscreenZINC OXIDEHALEM DERMATOLOGY PLLC35bc5ff5-8eb8-54cf-e063-6394a90ae3c22025-12-11Exact identifier
ndc (product): 85413-205
Ultimate Physical SunscreenZINC OXIDEHALEM DERMATOLOGY PLLC35be5dc0-861f-3738-e063-6394a90a23ca2025-12-11Exact identifier
ndc (package): 85413-205-13
ndc (product): 85413-205
ndc11 (package): 85413020513
spl id: 45b3b915-94a5-405e-e063-6294a90a666e
spl set id: 35be5dc0-861f-3738-e063-6394a90a23ca
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.