Home NDC 80641-009-01 Vacation SPF 30 Mineral
Product NDC 80641-009
Requested package NDC 80641-009-01
11-digit product format 806410009
Labeler code 80641
Product ID 80641-009_29b718d0-b18d-967e-e063-6294a90aa162
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Vacation Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-01
Substance ZINC OXIDE
Active strength 15.5 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 SPF 30 Mineral
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 15.5 g/100mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80641-009-01 Vacation SPF 30 Mineral 100 mL in 1 TUBE LOTION 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80641-009 VACATION SPF 30 MINERAL (ZINC OXIDE) LOTION [VACATION INC.] 2 Current NDC, 1 package rows 20241222_f69513ae-f210-075f-e053-2a95a90a9b2e.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 Sample Exclude flag Status 80641-009-01 80641000901 100 mL in 1 TUBE (80641-009-01) 100 ml 2023-01-01 No No Current