Avobenzone, Homosalate, Octisalate

Product NDC
0869-9055
11-digit product format
008699055
Labeler code
0869
Product ID
0869-9055_4cd5c03a-7450-d631-e063-6394a90adac0
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Vi-Jon, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-03
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0869-9055-34Avobenzone, Homosalate, Octisalate236 mL in 1 BOTTLE, PLASTICLOTION2365

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0869-9055AVOBENZONE, HOMOSALATE, OCTISALATE LOTION [VI-JON, LLC]4Current NDC, 1 package rows20250514_3da4706e-7c1a-435e-9603-e9aa98432018.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0869-9055-3400869905534236 mL in 1 BOTTLE, PLASTIC (0869-9055-34) 236 ml2023-05-03NoNoHistorical