Home NDC 80641-521 Vacation Instant Browning
Product NDC 80641-521
11-digit product format 806410521
Labeler code 80641
Product ID 80641-521_31f5a47a-94b3-282a-e063-6294a90a29fe
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone Octisalate Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Vacation Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-06
Substance AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength 2.9; 9.5; 4.9 g/100mL; g/100mL; g/100mL
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 Vacation Instant Browning
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2.9 g/100mL OCTOCRYLENE 9.5 g/100mL OCTISALATE 4.9 g/100mL
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 5A68WGF6WM Internal UNII lookup 4X49Y0596W 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 80641-521-10 Vacation Instant Browning 148 mL in 1 BOTTLE LOTION 148 2 80641-521-80 Vacation Instant Browning 30 mL in 1 BOTTLE LOTION 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80641-521 VACATION INSTANT BROWNING (AVOBENZONE OCTISALATE OCTOCRYLENE) LOTION [VACATION INC.] 2 Current NDC, 2 package rows 20250406_13028f61-3f62-22cc-e063-6394a90a6bf1.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 80641-521-10 80641052110 148 mL in 1 BOTTLE (80641-521-10) 148 ml 2024-03-06 No No Current 80641-521-80 80641052180 30 mL in 1 BOTTLE (80641-521-80) 30 ml 2024-03-06 No No Current