Home NDC 66820-0400 SEKKISEI HERBAL UV DEFENSE gel
Product NDC 66820-0400
11-digit product format 668200400
Labeler code 66820
Product ID 66820-0400_42ff269f-2905-3c40-e063-6394a90a323d
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE
Dosage form GEL
Route TOPICAL
Labeler KOS� America, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 30; 95; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 SEKKISEI HERBAL UV DEFENSE gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 95 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 26 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 66820-0400-1 SEKKISEI HERBAL UV DEFENSE gel 30 mL in 1 TUBE GEL 30 3 66820-0400-1 SEKKISEI HERBAL UV DEFENSE gel 1 in 1 CARTON GEL 1 3 66820-0400-2 SEKKISEI HERBAL UV DEFENSE gel 2 mL in 1 PACKET GEL 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66820-0400 SEKKISEI HERBAL UV DEFENSE GEL (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) GEL [KOSE AMERICA, INC.] 2 Current NDC, 3 package rows 20240316_cb0faa3a-68f8-49c5-8c28-3338b1b27cd8.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 81 of 353 · 7,049 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 66820-0400-1 66820040001 1 TUBE in 1 CARTON (66820-0400-1) / 30 mL in 1 TUBE 1 tube 2024-03-01 No No Current 66820-0400-2 66820040002 2 mL in 1 PACKET (66820-0400-2) 2 ml 2026-05-08 No No Current