Avobenzone, Homosalate, Octisalate

Product NDC
59450-947
11-digit product format
594500947
Labeler code
59450
Product ID
59450-947_4bd25620-3cc1-fefa-e063-6294a90a845b
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
The Kroger Co.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-22
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.644ec129-15c9-4ac1-8362-5b4c2e58ab9a2026-02-27Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

Adverse Reaction PROUDLY DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 Quality Guaranteed Kroger.com/guarantee 800-632-6900 For More Product Information, Scan UPC Using Your Kroger App or Call 800-632-6900

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
59450-947-30Avobenzone, Homosalate, Octisalate177 mL in 1 TUBELOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-947AVOBENZONE, HOMOSALATE, OCTISALATE LOTION [KROGER]2Current NDC, 1 package rows20250426_644ec129-15c9-4ac1-8362-5b4c2e58ab9a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59450-947-3059450094730177 mL in 1 TUBE (59450-947-30) 177 ml2024-10-29NoNoCurrent