FDA.reportPublic FDA data

Organys Open Formula Sheer

Manufacturer
Organys Beauty
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:38:26

Label at a glance#

ProductOrganys Open Formula Sheer
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Organys Open Formula Sheer

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Organys Open Formula Sheer

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Organys Open Formula Sheer

INDICATIONS & USAGE SECTION

Indication and UsageIndication and Usage

Organys Open Formula Sheer

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Organys Open Formula Sheer

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

Organys Open Formula Sheer

OTC - PURPOSE SECTION

purposepurpose

Organys Open Formula Sheer

WARNINGS SECTION

Warning LabelWarning Label

Organys Open Formula Sheer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83612-1391-1Organys Open Formula Sheer45 mL in 1 BOTTLE, PUMPLOTION453

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83612-139183612-1391-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETETH-20I835H2IHHXIACT
PULLULAN8ZQ0AYU1TTIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
PHENYLPROPANOL0F897O3O4MIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
XANTHAN GUMTTV12P4NEEIACT
ISOAMYL LAURATEM1SLX00M3MIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
TOCOPHEROLR0ZB2556P8IACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
SQUALANEGW89575KF9IACT
ZINC OXIDESOI2LOH54ZACTIB
CYCLODEXTRINS7E6SK9QDT8IACT
STEARETH-20L0Q8IK9E08IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-08-26full-release2026-06-01 01:11:49

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
Organys Open Formula SheerZINC OXIDEOrganys Beauty0b3ab551-cb66-cf86-e063-6394a90a7ab42025-10-09WarningsExact identifier
ndc (package): 83612-1391-1
ndc (product): 83612-1391
ndc11 (package): 83612139101
spl id: 40c03d65-8d07-371a-e063-6294a90a7ac6
spl set id: 0b3ab551-cb66-cf86-e063-6394a90a7ab4

Reported adverse events (FAERS/openFDA)#

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