Home NDC 80641-001 VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
Product NDC 80641-001
11-digit product format 806410001
Labeler code 80641
Product ID 80641-001_47224083-a029-4253-9660-b228c66263ff
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Vacation Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-15
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 25; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL
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 CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 25 mg/mL HOMOSALATE 100 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 80 mg/mL
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80641-001-01 VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN 100 mL in 1 TUBE LOTION 100 8 80641-001-02 VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN 30 mL in 1 TUBE LOTION 30 8 80641-001-03 VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN 7 mL in 1 PACKET LOTION 7 8 80641-001-04 VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN 177 mL in 1 TUBE LOTION 177 8 80641-001-04 VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN 2 in 1 KIT LOTION 2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80641-001 VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [VACATION INC.] 5 Current NDC, Legacy NDC, 5 package rows 20250109_c7794831-52d1-4d80-936d-44af18ae0472.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 81 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80641-001-01 80641000101 100 mL in 1 TUBE (80641-001-01) 100 ml 2022-04-06 0000-00-00 No No Current 80641-001-02 80641000102 30 mL in 1 TUBE (80641-001-02) 30 ml 2022-04-06 0000-00-00 No No Current 80641-001-03 80641000103 7 mL in 1 PACKET (80641-001-03) 7 ml 2022-04-06 0000-00-00 No No Current 80641-001-04 80641000104 2 TUBE in 1 KIT (80641-001-04) / 177 mL in 1 TUBE 2 tube 2024-03-01 No No Current