Home NDC 63645-184 SPF 30 - Zinc Oxide Lip Balm
Product NDC 63645-184
11-digit product format 636450184
Labeler code 63645
Product ID 63645-184_340695fd-9754-d58a-e063-6294a90a75c9
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler OraLabs
Application 352
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-03
Substance ZINC OXIDE
Active strength 150 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base SPF 30 - Zinc Oxide Lip Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 150 mg/g
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 63645-184-01 SPF 30 - Zinc Oxide Lip Balm 4 g in 1 CONTAINER STICK 4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63645-184 SPF 30 - ZINC OXIDE LIP BALM (ZINC OXIDE) STICK [ORALABS] 1 Current NDC, 1 package rows 20250502_482aeef8-8042-4b47-8dbf-ea7687acc5dd.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63645-184-01 63645018401 4 g in 1 CONTAINER (63645-184-01) 4 g 2025-02-03 No No Current