VACATION CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN

Product NDC
80641-003
Requested package NDC
80641-003-01
11-digit product format
806410003
Labeler code
80641
Product ID
80641-003_ee49afda-445f-4e8d-8a3b-3d83d8dfba05
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form
OIL
Route
TOPICAL
Labeler
Vacation Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-05-19
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80641-00380641-003-01DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-003VACATION CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) OIL [VACATION INC.]4Legacy NDC20240302_11d5f618-98eb-4da0-9535-e068bc0c2d04.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80641-003-0180641000301100 mL in 1 BOTTLE (80641-003-01) 100 ml2021-05-190000-00-00NoNoCurrent