FDA.reportPublic FDA data

Vacation SPF 50 Classic

Product NDC
80641-007
11-digit product format
806410007
Labeler code
80641
Product ID
80641-007_2ee97a94-d5a2-e05d-e063-6394a90a709b
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Vacation Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
2.9; 8.8; 4.9; 8.6 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vacation SPF 50 Classic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2.9 g/100mL
HOMOSALATE8.8 g/100mL
OCTISALATE4.9 g/100mL
OCTOCRYLENE8.6 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-007-01Vacation SPF 50 Classic177 mL in 1 CANSPRAY1773
80641-007-02Vacation SPF 50 Classic50 mL in 1 CANSPRAY503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-007VACATION SPF 50 CLASSIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [VACATION INC.]3Current NDC, 2 package rows20250226_f2780cb5-063c-10d3-e053-2995a90a8576.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-007-0180641000701177 mL in 1 CAN (80641-007-01) 177 ml2022-12-01NoNoCurrent
80641-007-028064100070250 mL in 1 CAN (80641-007-02) 50 ml2025-02-24NoNoCurrent