FDA.reportPublic FDA data

Organys Derma Made

Manufacturer
Organys Beauty
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:38:26

Label at a glance#

ProductOrganys Derma Made
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Organys Derma Made

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Organys Derma Made

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Organys Derma Made

WARNINGS SECTION

Warning LabelWarning Label

Organys Derma made

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Organys Derma Made

INDICATIONS & USAGE SECTION

Indication and UsageIndication and Usage

Organys Derma Made

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

Organys Derma Made

OTC - PURPOSE SECTION

purposepurpose

Organys Derma Made

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83612-0282-1Organys Derma Made45 mL in 1 BOTTLE, PUMPLOTION455
83612-0282-2Organys Derma Made5 mL in 1 BOTTLELOTION55
83612-0282-3Organys Derma Made45 mL in 1 TUBELOTION455

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
83612-028283612-0282-1, 83612-0282-2, 83612-0282-3

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
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
TRILAURETH-4 PHOSPHATEM96W2OLL2VIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
ISODODECANEA8289P68Y2IACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ZINC OXIDESOI2LOH54ZACTIB
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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-08-06full-release2026-06-01 01:09:25

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 Derma MadeZINC OXIDEOrganys Beauty09b8b8c0-4066-9cbe-e063-6394a90aca242025-10-09WarningsExact identifier
ndc (package): 83612-0282-1
ndc (package): 83612-0282-3
ndc (package): 83612-0282-2
ndc (product): 83612-0282
ndc11 (package): 83612028203
ndc11 (package): 83612028201
ndc11 (package): 83612028202
spl id: 40c0942a-1318-6a67-e063-6294a90af373
spl set id: 09b8b8c0-4066-9cbe-e063-6394a90aca24

Reported adverse events (FAERS/openFDA)#

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