Home NDC 83286-014 Broad Spectrum SPF45
Product NDC 83286-014
11-digit product format 832860014
Labeler code 83286
Product ID 83286-014_4f1a74ff-5ef6-4174-bb9b-b3ade1dc4f9c
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Octinoxate
Dosage form GEL
Route TOPICAL
Labeler Drmtlgy, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-01
Substance ZINC OXIDE; OCTINOXATE
Active strength 12; 7.5 g/100mL; g/100mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Broad Spectrum SPF45
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 12 g/100mL OCTINOXATE 7.5 g/100mL
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 4Y5P7MUD51 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 83286-014-01 Broad Spectrum SPF45 50 mL in 1 BOTTLE GEL 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83286-014 BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTINOXATE) GEL [DRMTLGY, LLC] 1 Current NDC, 1 package rows 20250508_0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8.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 81 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 83286-014-01 83286001401 50 mL in 1 BOTTLE (83286-014-01) 50 ml 2025-05-01 No No Current