Home NDC 61649-045 ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose
Product NDC 61649-045
11-digit product format 616490045
Labeler code 61649
Product ID 61649-045_41997acb-88d2-c8da-e063-6294a90ad450
Type HUMAN OTC DRUG
Nonproprietary name Zinc oxide
Dosage form STICK
Route TOPICAL
Labeler 9055-7588 Quebec Inc. DBA Attitude
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-01
Substance ZINC OXIDE
Active strength 20 g/100g
NDC exclude flag No
Listing certified through 2026-12-31
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 ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20 g/100g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61649-045-08 ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose 8.5 g in 1 CARTON STICK 8.5 2 61649-045-08 ATTITUDE Oceanly Phyto-Sun Kit SPF 30 8.5 g in 1 CARTON STICK 8.5 g 20 g in 100g 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61649-045 ATTITUDE OCEANLY PHYTO-SUN KIT SPF 30 (ZINC OXIDE) KIT [9055-7588 QUEBEC INC. DBA ATTITUDE] 1 Current NDC 20240402_0eae4b71-60be-9715-e063-6294a90af463.zip 61649-045 ATTITUDE OCEANLY PHYTO-SUN LIP BALM SPF 30 BABY ROSE (ZINC OXIDE) STICK [9055-7588 QUEBEC INC. DBA ATTITUDE] 1 Current NDC, 1 package rows 20240402_0e9d9419-a7e1-bc42-e063-6394a90af511.zip
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 26 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 61649-045-08 61649004508 8.5 g in 1 CARTON (61649-045-08) 8.5 g 2024-04-01 No No Current