FDA.reportPublic FDA data

Iris and Romeo Weekend Skin

Manufacturer
Iris and Romeo
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:41:39

Label at a glance#

ProductIris and Romeo Weekend Skin
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Iris and Romeo Weekend Skin

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Iris and Romeo Weekend Skin

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Iris and Romeo Weekend Skin

INDICATIONS & USAGE SECTION

Indications & usageIndications & usage

Iris and Romeo Weekend Skin

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Iris and Romeo Weekend Skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

Iris and Romeo Weekend Skin

OTC - PURPOSE SECTION

purposepurpose

Iris and Romeo Weekend Skin

WARNINGS SECTION

Warning LabelWarning Label

Iris and Romeo

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
83247-1321-1Iris and Romeo Weekend Skin35 mL in 1 TUBELOTION355
83247-1321-2Iris and Romeo Weekend Skin1 in 1 CARTONLOTION15
83247-1321-3Iris and Romeo Weekend Skin15 mL in 1 TUBELOTION155
83247-1321-4Iris and Romeo Weekend Skin1 in 1 CARTONLOTION15

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83247-132183247-1321-1, 83247-1321-2, 83247-1321-3, 83247-1321-4

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
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
DIMETHICONE92RU3N3Y1OIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALLANTOIN344S277G0ZIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PHENYLPROPANOL0F897O3O4MIACT
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE687U3PEB2YIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
ZINC OXIDESOI2LOH54ZACTIB
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MICAV8A1AW0880IACT
TOCOPHEROLR0ZB2556P8IACT
STANNIC OXIDEKM7N50LOS6IACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-08-14full-release2026-06-01 01:10:27

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
Iris and Romeo Weekend SkinZINC OXIDEIris and Romeo0828a345-0178-1503-e063-6394a90a7d242025-10-31WarningsExact identifier
ndc (package): 83247-1321-3
ndc (package): 83247-1321-2
ndc (package): 83247-1321-1
ndc (package): 83247-1321-4
ndc (product): 83247-1321
ndc11 (package): 83247132101
ndc11 (package): 83247132103
ndc11 (package): 83247132104
ndc11 (package): 83247132102
spl id: 42796fc4-03bd-3b02-e063-6394a90af2ab
spl set id: 0828a345-0178-1503-e063-6394a90a7d24

Reported adverse events (FAERS/openFDA)#

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