Home NDC 84281-477 SUMMER GELEE SPF-30
Product NDC 84281-477
11-digit product format 842810477
Labeler code 84281
Product ID 84281-477_171b43a9-7f61-f8ff-e063-6294a90ab5fb
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form GEL
Route TOPICAL
Labeler SUMMER GELEE LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-06
Substance HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 100; 50; 50 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 SUMMER GELEE SPF-30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 100 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V06SV4M95S Internal UNII lookup 4X49Y0596W Internal UNII lookup 5A68WGF6WM Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84281-477-00 SUMMER GELEE SPF-30 92.26 mL in 1 TUBE GEL 92.26 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84281-477 SUMMER GELEE SPF-30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [SUMMER GELEE LLC] 1 Current NDC, 1 package rows 20240507_bc85db65-2acc-4b39-9189-f8916c487b61.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 84281-477-00 84281047700 92.26 mL in 1 TUBE (84281-477-00) 92.26 ml 2024-05-06 No No Current