Home NDC 80641-105 Vacation X AZ Lemon Tea Lip Balm SPF 30
Product NDC 80641-105
11-digit product format 806410105
Labeler code 80641
Product ID 80641-105_b534b67f-bb13-493c-9f99-be20cf1fae35
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form LIPSTICK
Route TOPICAL
Labeler Vacation INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-15
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 30; 50; 30; 100 mg/g; mg/g; mg/g; mg/g
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 X AZ Lemon Tea Lip Balm SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/g HOMOSALATE 50 mg/g OCTISALATE 30 mg/g OCTOCRYLENE 100 mg/g
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 80641-105-01 Vacation X AZ Lemon Tea Lip Balm SPF 30 4.25 g in 1 TUBE LIPSTICK 4.25 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 80641-105-01 80641010501 4.25 g in 1 TUBE (80641-105-01) 4.25 g 2022-01-15 No No Current