Home NDC 83326-002 Zealios SPF LipGuard
Product NDC 83326-002
11-digit product format 833260002
Labeler code 83326
Product ID 83326-002_65123dc9-9354-4015-8507-d8d4e6bc2e01
Type HUMAN OTC DRUG
Nonproprietary name OCTISALATE and AVOBENZONE
Dosage form GEL
Route TOPICAL
Labeler Personal Best Products Inc. dba Zealios
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-06-21
Substance OCTISALATE; AVOBENZONE
Active strength 50; 30 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 83326-002 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 83326-002 83326-002-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 Zealios SPF LipGuard
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 50 mg/mL AVOBENZONE 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4X49Y0596W Internal UNII lookup G63QQF2NOX 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 83326-002-01 Zealios SPF LipGuard 7.39 mL in 1 TUBE, WITH APPLICATOR GEL 7.39 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83326-002 ZEALIOS SPF LIPGUARD (OCTISALATE AND AVOBENZONE) GEL [PERSONAL BEST PRODUCTS INC. DBA ZEALIOS] 2 Current NDC, 1 package rows 20250119_3a07822b-a7c9-40af-a8f7-bea591c7a49b.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 155 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 83326-002-01 83326000201 7.39 mL in 1 TUBE, WITH APPLICATOR (83326-002-01) 7.39 ml 2021-06-21 No No Current