Home NDC 83247-2489 Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn
Product NDC 83247-2489
11-digit product format 832472489
Labeler code 83247
Product ID 83247-2489_52bb47b9-b6d3-213d-e063-6294a90a11df
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 2025-02-21
Substance ZINC OXIDE
Active strength 110 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 110 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83247-2489-1 Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn 6.5 mL in 1 BOTTLE, WITH APPLICATOR LOTION 6.5 1 83247-2489-2 Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn 1 in 1 CARTON LOTION 1 1
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 45 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83247-2489-1 83247248901 6.5 mL in 1 BOTTLE, WITH APPLICATOR 6.5 ml Historical 83247-2489-2 83247248902 1 BOTTLE, WITH APPLICATOR in 1 CARTON (83247-2489-2) / 6.5 mL in 1 BOTTLE, WITH APPLICATOR (83247-2489-1) 2025-02-21 No No Current