FDA.reportPublic FDA data

Essential Mineral Sun Protection

Manufacturer
Fern Burg | 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 01:21:51

Label at a glance#

ProductEssential Mineral Sun Protection
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product labelProduct label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85387-258-50Essential Mineral Sun Protection53 g in 1 BOTTLE, PUMPCREAM532

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85387-25885387-258-50
58892-258

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
CI 774911K09F3G675IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
TOCOPHEROLR0ZB2556P8IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ETHYLHEXYL HYDROXYSTEARATE BENZOATE3W8F25684BIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
ISOHEXADECANE918X1OUF1EIACT
ISODODECANEA8289P68Y2IACT
CI 77492EX438O2MRTIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CI 77499XM0M87F357IACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TRIETHANOLAMINE9O3K93S3TKIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
MICAV8A1AW0880IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
ZINC OXIDESOI2LOH54ZACTIB
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CETEARETH-20YRC528SWUYIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
BISMUTH OXYCHLORIDE4ZR792I587IACT

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
Essential Mineral Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEFern Burg34a360b2-6798-c7e8-e063-6294a90a5cbb2025-12-11Exact identifier
ndc (package): 85387-258-50
ndc (product): 85387-258
ndc11 (package): 85387025850
spl id: 45b370ec-f575-b104-e063-6294a90a105b
spl set id: 34a360b2-6798-c7e8-e063-6294a90a5cbb
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
ndc (product): 58892-258

Reported adverse events (FAERS/openFDA)#

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