Avobenzone, Homosalate, Octisalate

Product NDC
75712-934
11-digit product format
757120934
Labeler code
75712
Product ID
75712-934_4c10d447-9184-5d06-e063-6394a90a7f1a
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
2023-08-25
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 150; 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
HOMOSALATE150 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
75712-934-21Avobenzone, Homosalate, Octisalate88 mL in 1 TUBELOTION885

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75712-934AVOBENZONE, HOMOSALATE, OCTISALATE LOTION [OLD EAST MAIN CO.]3Current NDC, 1 package rows20241013_cea1c223-c9d4-42ac-8c5b-c0ca647d57a1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75712-934-217571209342188 mL in 1 TUBE (75712-934-21) 88 ml2023-08-25NoNoCurrent