Home NDC 80641-520 Vacation Lip Balm
Product NDC 80641-520
11-digit product format 806410520
Labeler code 80641
Product ID 80641-520_7d6947d5-8d03-4bf2-8ca7-0847efa7c0cc
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form GEL
Route TOPICAL
Labeler Vacation INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 3; 3; 4; 10 g/100mL; g/100mL; g/100mL; g/100mL
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 Vacation Lip Balm
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100mL HOMOSALATE 3 g/100mL OCTISALATE 4 g/100mL OCTOCRYLENE 10 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 80641-520-01 Vacation Lip Balm 15 mL in 1 TUBE GEL 15 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 109 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 80641-520-01 80641052001 15 mL in 1 TUBE (80641-520-01) 15 ml 2026-01-01 No No Current