Avobenzone, Homosalate, Octisalate

Product NDC
75712-947
11-digit product format
757120947
Labeler code
75712
Product ID
75712-947_4c112ee8-7b3d-69da-e063-6294a90a906b
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Old East Main Co.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-31
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 120; 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
HOMOSALATE120 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
75712-947-34Avobenzone, Homosalate, Octisalate236 mL in 1 BOTTLE, PLASTICLOTION2364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75712-947AVOBENZONE, HOMOSALATE, OCTISALATE LOTION [OLD EAST MAIN CO.]2Current NDC, 1 package rows20241013_ce9a2139-c5c2-43e2-bd51-1f14ace594d9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75712-947-3475712094734236 mL in 1 BOTTLE, PLASTIC (75712-947-34) 236 ml2023-08-31NoNoCurrent