Avobenzone, Homosalate, Octisalate

Product NDC
11344-943
11-digit product format
113440943
Labeler code
11344
Product ID
11344-943_4ceb123b-d7bf-f068-e063-6394a90af7a1
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-08
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 120; 50 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Avobenzone, Homosalate, Octisalate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE120 mg/g
OCTISALATE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-943-34Avobenzone, Homosalate, Octisalate156 g in 1 BOTTLE, SPRAYSPRAY1563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-943AVOBENZONE, HOMOSALATE, OCTISALATE SPRAY [CONSUMER PRODUCT PARTNERS, LLC]1Current NDC, 1 package rows20241109_af052521-bfa6-4142-a10b-ef51f474a077.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-943-3411344094334156 g in 1 BOTTLE, SPRAY (11344-943-34) 156 g2024-11-08NoNoCurrent