Home NDC 84378-103 Anti Aging Lip Balm Pot SPF 15
Product NDC 84378-103
11-digit product format 843780103
Labeler code 84378
Product ID 84378-103_56331742-cd4b-67d5-e063-6294a90aa19d
Type HUMAN OTC DRUG
Nonproprietary name Lip Balm
Dosage form OINTMENT
Route TOPICAL
Labeler Epicuren Disocovery
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-07
Substance AVOBENZONE; OCTISALATE; OCTINOXATE
Active strength 3; 4.5; 7.5 g/100g; g/100g; g/100g
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 Anti Aging Lip Balm Pot SPF 15
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100g OCTISALATE 4.5 g/100g OCTINOXATE 7.5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 4X49Y0596W Internal UNII lookup 4Y5P7MUD51 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 84378-103-07 Anti Aging Lip Balm Pot SPF 15 7 g in 1 JAR OINTMENT 7 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 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 84378-103-07 84378010307 7 g in 1 JAR (84378-103-07) 7 g 2025-10-07 No No Current