FDA.reportPublic FDA data

OMIC MINERAL SUNSCREEN

Manufacturer
Mitchell Cosmetics, Inc | Mitchell Cosmetics, Inc. | Mitchell Cosmetics Distribution LLC
Effective date
2026-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-10-13 04:04:18

Label at a glance#

ProductOMIC MINERAL SUNSCREEN
Active ingredientZINC OXIDE
Label structure15 sections

Label contents#

Full prescribing information#

INSTRUCTIONS FOR USE SECTION

DirectionsDirections

OTC - ACTIVE INGREDIENT SECTION

Active InngredientsActive Inngredients

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

WARNINGS SECTION

WarningsWarnings

STATEMENT OF IDENTITY SECTION

Mineral Sunscreen Broad SpectrumMineral Sunscreen Broad Spectrum

STORAGE AND HANDLING SECTION

Other InformationOther Information

OTC - ASK DOCTOR SECTION

Stop use and ask doctorStop use and ask doctor

OTC - DO NOT USE SECTION

Do Not UseDo Not Use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

OTC - PURPOSE SECTION

Active Ingredients and PurposeActive Ingredients and Purpose

OTC - WHEN USING SECTION

When using this productWhen using this product

INDICATIONS & USAGE SECTION

UsesUses

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Omic Mineral SunscreenOmic Mineral Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts and Country of LabelingDrug Facts and Country of Labeling

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrco.de/beZBAPback pcp with drug facts.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

Products#

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

DailyMed product names page 1 of 2 · 80 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79009-90279009-902-80

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 79 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
CETEARETH-20YRC528SWUYIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
XANTHAN GUMTTV12P4NEEIACT
POLYSORBATE 207T1F30V5YHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BEHENYL ALCOHOL9G1OE216XYIACT
LEUCINEGMW67QNF9CIACT
SODIUM LACTATETU7HW0W0QTIACT
ARGININE94ZLA3W45FIACT
PCASZB83O1W42IACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM PCA469OTG57A2IACT
PROPANEDIOL5965N8W85TIACT
SODIUM CHLORIDE451W47IQ8XIACT
PENTYLENE GLYCOL50C1307PZGIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALANINEOF5P57N2ZXIACT
CI 774911K09F3G675IACT
EDETATE DISODIUM7FLD91C86KIACT
ALLANTOIN344S277G0ZIACT
BISABOLOL24WE03BX2TIACT
POLYGLYCERYL-10 PENTASTEARATEPMX5872701IACT
CI 77492EX438O2MRTIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BERGAMOT OIL39W1PKE3JIIACT
POLYURETHANE-62TBK645J3J8IACT
CERAMIDE 988KCS7120EIACT
CERAMIDE NP4370DF050BIACT
CITRUS PARADISI (GRAPEFRUIT) SEED OIL598D944HOLIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
PLATELET GLYCOPROTEIN VIL2RO3AL4JNIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
ARGANIA SPINOSA KERNEL OIL4V59G5UW9XIACT
GLYCINETE7660XO1CIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
LAURETH-7Z95S6G8201IACT
CERAMIDE APF1X8L2B00JIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-07-10daily-update2026-07-17 21:45:34
12026-02-25full-release2026-06-01 01:48:14

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
56426f74-5a79-1d34-e063-6394a90a08704bab742b-cc69-c582-e063-6394a90a4d542026-07-10WarningsExact identifier
spl set id: 4bab742b-cc69-c582-e063-6394a90a4d54

Reported adverse events (FAERS/openFDA)#

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