Home NDC 81100-501 ISNTREE HYALURONIC ACID DAILY SUNGEL
Product NDC 81100-501
11-digit product format 811000501
Labeler code 81100
Product ID 81100-501_4dd8cb8b-2b7a-6e0c-e063-6294a90a193e
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate
Dosage form CREAM
Route TOPICAL
Labeler ISNTREE Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-17
Substance HOMOSALATE; AVOBENZONE; OCTISALATE
Active strength 4.5; 1.35; 2.25 g/50mL; g/50mL; g/50mL
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 ISNTREE HYALURONIC ACID DAILY SUNGEL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 4.5 g/50mL AVOBENZONE 1.35 g/50mL OCTISALATE 2.25 g/50mL
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 G63QQF2NOX Internal UNII lookup 4X49Y0596W Internal UNII lookup
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 81100-501-01 ISNTREE HYALURONIC ACID DAILY SUNGEL 50 mL in 1 TUBE CREAM 50 5 81100-501-02 ISNTREE HYALURONIC ACID DAILY SUNGEL 1 in 1 BOX CREAM 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81100-501 ISNTREE HYALURONIC ACID DAILY SUNGEL (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [ISNTREE INC.] 4 Current NDC, 2 package rows 20240725_0ef5d5ce-3bdf-dffc-e063-6394a90aad54.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 81100-501-01 81100050101 50 mL in 1 TUBE 50 ml Historical 81100-501-02 81100050102 1 TUBE in 1 BOX (81100-501-02) / 50 mL in 1 TUBE (81100-501-01) 1 tube 2024-01-17 No No Current