FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate

Product NDC
79481-0939
11-digit product format
794810939
Labeler code
79481
Product ID
79481-0939_4b9840e0-e424-3a84-e063-6394a90a09f6
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Meijer, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-07
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 100; 50 mg/mL; mg/mL; mg/mL
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/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0939-1Avobenzone, Homosalate, Octisalate236 mL in 1 BOTTLE, PLASTICLOTION2365
79481-0939-2Avobenzone, Homosalate, Octisalate89 mL in 1 TUBELOTION895

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0939AVOBENZONE, HOMOSALATE, OCTISALATE LOTION [MEIJER DISTRIBUTION, INC]3Current NDC, 2 package rows20240824_95ba2b33-f593-4e95-bd6e-5910d6aa5158.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0939-179481093901236 mL in 1 BOTTLE, PLASTIC (79481-0939-1) 236 ml2023-08-07NoNoHistorical
79481-0939-27948109390289 mL in 1 TUBE (79481-0939-2) 89 ml2023-08-07NoNoHistorical