FDA.reportPublic FDA data

Iris and Romeo Weekend Skin

Product NDC
83247-1321
11-digit product format
832471321
Labeler code
83247
Product ID
83247-1321_42796fc4-03bd-3b02-e063-6394a90af2ab
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Iris and Romeo
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-02
Substance
ZINC OXIDE
Active strength
132 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Iris and Romeo Weekend Skin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE132 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83247-1321IRIS AND ROMEO WEEKEND SKIN (ZINC OXIDE) LOTION [IRIS AND ROMEO]3Current NDC, 4 package rows20241027_0828a345-0178-1503-e063-6394a90a7d24.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83247-1321-18324713210135 mL in 1 TUBE35 mlHistorical
83247-1321-2832471321021 TUBE in 1 CARTON (83247-1321-2) / 35 mL in 1 TUBE (83247-1321-1) 1 tube2022-05-02NoNoCurrent
83247-1321-38324713210315 mL in 1 TUBE15 mlHistorical
83247-1321-4832471321041 TUBE in 1 CARTON (83247-1321-4) / 15 mL in 1 TUBE (83247-1321-3) 1 tube2024-02-15NoNoCurrent