Home NDC 68577-199 HERBAL UV DEFENSE SPF40
Product NDC 68577-199
11-digit product format 685770199
Labeler code 68577
Product ID 68577-199_2a76fea4-6ab0-5908-e063-6394a90afe4e
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octisalate, Avobenzone, Octocrylene
Dosage form GEL
Route TOPICAL
Labeler COSMAX USA, CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-03
Substance HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength 9.5; 5; 3; 2.6 mg/100mg; mg/100mg; mg/100mg; mg/100mg
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 HERBAL UV DEFENSE SPF40
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 9.5 mg/100mg OCTISALATE 5 mg/100mg AVOBENZONE 3 mg/100mg OCTOCRYLENE 2.6 mg/100mg
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 68577-199-00 HERBAL UV DEFENSE SPF40 30 mg in 1 TUBE GEL 30 1 68577-199-00 HERBAL UV DEFENSE SPF40 1 in 1 CARTON GEL 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68577-199 HERBAL UV DEFENSE SPF40 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) GEL [COSMAX USA, CORPORATION] 1 Current NDC, 2 package rows 20250101_2a76fd94-2f1f-e6d8-e063-6294a90a287c.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68577-199-00 68577019900 1 TUBE in 1 CARTON (68577-199-00) / 30 mg in 1 TUBE 1 tube 2024-01-03 No No Current