Home NDC 58518-021 SURFERS BARRIER SPF 50
Product NDC 58518-021
11-digit product format 585180021
Labeler code 58518
Product ID 58518-021_4953db07-e703-5cf0-e063-6394a90a1cad
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE, TITANIUM DIOXIDE
Dosage form STICK
Route TOPICAL
Labeler Avasol LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-01-02
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 24.5; 6 g/100g; g/100g
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 SURFERS BARRIER SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 24.5 g/100g TITANIUM DIOXIDE 6 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58518-021-01 SURFERS BARRIER SPF 50 28 g in 1 TUBE STICK 28 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58518-021 SURFERS BARRIER SPF 50 (ZINC OXIDE, TITANIUM DIOXIDE) STICK [AVASOL LLC] 4 Current NDC, Legacy NDC, 1 package rows 20241004_ec55eef0-17e6-416d-bd5e-548f2f323cea.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 162 of 353 · 7,049 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58518-021-01 58518002101 28 g in 1 TUBE (58518-021-01) 28 g 2020-01-02 0000-00-00 No No Current