FDA.reportPublic FDA data

Organys Open Formula Tinted

Manufacturer
Organys Beauty | Nanophase Technologies Corporation
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:53:12

Label at a glance#

ProductOrganys Open Formula Tinted
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Organys Open Formula Tinted

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Organys Open Formula Tinted

INACTIVE INGREDIENT SECTION

inactive ingredientsinactive ingredients

Organys Open Formula Tinted

INDICATIONS & USAGE SECTION

Indication and UsageIndication and Usage

Organys Open Formula Tinted

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Organys Open Formula Tinted

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

Organys Open Formula Tinted

OTC - PURPOSE SECTION

purposepurpose

Organys Open Formula Tinted

WARNINGS SECTION

Warning LabelWarning Label

Organys Open Formula Tinted

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83612-1330ORGANYS OPEN FORMULA TINTED (ZINC OXIDE) LOTION [ORGANYS BEAUTY]3Unmatched20241009_0b3a8cc1-a496-e1e5-e063-6394a90a1c06.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83612-133083612-1330-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)9KB5R958PBIACT
PROPANEDIOL5965N8W85TIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
.BETA.-TOCOPHEROL9U6A490501IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
TRILAURETH-4 PHOSPHATEM96W2OLL2VIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
ISODODECANEA8289P68Y2IACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ZINC OXIDESOI2LOH54ZACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
23e35a91-90d4-c81c-e063-6394a90aa8e00b3a8cc1-a496-e1e5-e063-6394a90a1c062024-10-07WarningsExact identifier
spl id: 23e35a91-90d4-c81c-e063-6394a90aa8e0
spl set id: 0b3a8cc1-a496-e1e5-e063-6394a90a1c06

Reported adverse events (FAERS/openFDA)#

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