FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate

Product NDC
55910-442
11-digit product format
559100442
Labeler code
55910
Product ID
55910-442_4c110e1b-5525-3dea-e063-6294a90a97f6
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Old East Main Co.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-25
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
55910-442-14Avobenzone, Homosalate, Octisalate156 g in 1 BOTTLE, SPRAYSPRAY1565
55910-442-39Avobenzone, Homosalate, Octisalate312 g in 1 BOTTLE, SPRAYSPRAY3125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-442AVOBENZONE, HOMOSALATE, OCTISALATE SPRAY [OLD EAST MAIN CO.]3Current NDC, 2 package rows20240727_b3d2da09-d9c9-4c27-82fe-a434ece2f099.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-442-1455910044214156 g in 1 BOTTLE, SPRAY (55910-442-14) 156 g2023-08-11NoNoCurrent
55910-442-3955910044239312 g in 1 BOTTLE, SPRAY (55910-442-39) 312 g2023-08-11NoNoCurrent