Home NDC 68577-197 SOLAR MILK SPF50
Product NDC 68577-197
11-digit product format 685770197
Labeler code 68577
Product ID 68577-197_29fe4dad-d1fc-e750-e063-6294a90ab307
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form GEL
Route TOPICAL
Labeler COSMAX USA, CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-01
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength 3; 15; 10; 5 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base SOLAR MILK SPF50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 mg/mL HOMOSALATE 15 mg/mL OCTOCRYLENE 10 mg/mL OCTISALATE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68577-197-00 SOLAR MILK SPF50 1 in 1 CARTON GEL 1 1 68577-197-00 SOLAR MILK SPF50 50 mL in 1 BOTTLE GEL 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68577-197 SOLAR MILK SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [COSMAX USA, CORPORATION] 1 Current NDC, 2 package rows 20241227_29fe4dad-d1fb-e750-e063-6294a90ab307.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 242 of 353 · 7,041 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68577-197-00 68577019700 1 BOTTLE in 1 CARTON (68577-197-00) / 50 mL in 1 BOTTLE 1 bottle 2024-09-01 No No Current