Home NDC 83286-008 Broad Spectrum SPF45
Product NDC 83286-008
11-digit product format 832860008
Labeler code 83286
Product ID 83286-008_f6752fc2-97f8-4812-bd32-c91fb9b703be
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 2025-04-08
Marketing end 2027-04-30
Substance ZINC OXIDE; OCTINOXATE
Active strength 12; 7.5 g/100g; g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
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 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 12 g/100g OCTINOXATE 7.5 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 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 83286-008-01 Broad Spectrum SPF45 57 g in 1 BOTTLE GEL 57 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83286-008 BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTINOXATE) GEL [DRMTLGY, LLC] 2 Current NDC, 1 package rows 20250508_ce93b371-26ab-4493-98e0-98234c3a9ba6.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 Marketing end Sample Exclude flag Status 83286-008-01 83286000801 57 g in 1 BOTTLE (83286-008-01) 57 g 2025-04-08 2027-04-30 No No Historical