Home NDC 83286-002 SPF 25 LIP BALM
Product NDC 83286-002
11-digit product format 832860002
Labeler code 83286
Product ID 83286-002_cdf9642a-e3c6-457d-88a4-88562627bda6
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octisalate, Homosalate
Dosage form PASTE
Route TOPICAL
Labeler Drmtlgy, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-18
Substance AVOBENZONE; OCTISALATE; HOMOSALATE
Active strength 3; 5; 10 g/100g; g/100g; g/100g
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 SPF 25 LIP BALM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100g OCTISALATE 5 g/100g HOMOSALATE 10 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 4X49Y0596W Internal UNII lookup V06SV4M95S 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 83286-002-01 SPF 25 LIP BALM 7 g in 1 TUBE PASTE 7 2 83286-002-01 SPF 25 LIP BALM 1 in 1 CARTON PASTE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83286-002 SPF 25 LIP BALM (AVOBENZONE, OCTISALATE, HOMOSALATE) PASTE [DRMTLGY, LLC] 1 Current NDC, 2 package rows 20240209_8aed2fb0-f7b8-4ff0-b597-144c0557789e.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 83286-002-01 83286000201 1 TUBE in 1 CARTON (83286-002-01) / 7 g in 1 TUBE 1 tube 2024-01-18 No No Current