FDA.reportPublic FDA data

Ultra Solar Shield non-tinted moisturizing mineral SPF 40

Manufacturer
Joyce Kelly Enterprises | Custom Analytics LLC | Fragrance Manufacturing INC | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:07

Label at a glance#

ProductUltra Solar Shield non-tinted moisturizing mineral SPF 40
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-130385632205048GTIN-13: 0385632205048
EAN-13: 0385632205048
GTIN-12: 385632205048
UPC-A: 385632205048
GTIN storage (14 digits): 00385632205048		BEACH 205.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85632-205-04Ultra Solar Shield non-tinted moisturizing mineral SPF 40113 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
85632-20585632-205-04
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
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
POLYSORBATE 207T1F30V5YHIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TRIETHANOLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM CHLORIDE451W47IQ8XIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
GLYCERINPDC6A3C0OXIACT

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
Ultra Solar Shield non-tinted moisturizing mineral SPF 40ZINC OXIDEJoyce Kelly Enterprises365bdf7a-c034-beef-e063-6394a90a4dd72025-12-08Exact identifier
ndc (package): 85632-205-04
ndc (product): 85632-205
ndc11 (package): 85632020504
spl id: 45776ebb-6690-6128-e063-6294a90a59ca
spl set id: 365bdf7a-c034-beef-e063-6394a90a4dd7
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.