Home NDC 58418-004 2000DL-CL30T
Product NDC 58418-004
11-digit product format 584180004
Labeler code 58418
Product ID 58418-004_4c12935a-a071-488e-e063-6394a90aa6d3
Type HUMAN OTC DRUG
Nonproprietary name SPF30 BS Tropical
Dosage form LOTION
Route TOPICAL
Labeler Epic Laboratories, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-01
Substance OCTOCRYLENE; AVOBENZONE
Active strength 2.34; .9 g/30mL; g/30mL
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 2000DL-CL30T
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 2.34 g/30mL AVOBENZONE .9 g/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup G63QQF2NOX Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58418-004-06 2000DL-CL30T 177 mL in 1 TUBE LOTION 177 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58418-004 2000DL-CL30T (SPF30 BS TROPICAL) LOTION [EPIC LABORATORIES, LLC] 4 Current NDC, 1 package rows 20250101_0286f94e-a2e8-b529-e063-6294a90ac08d.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 58418-004-06 58418000406 177 mL in 1 TUBE (58418-004-06) 177 ml 2023-10-02 No No Current