Home NDC 84307-486 SABIYA Broad Spectrum SPF-50
Product NDC 84307-486
11-digit product format 843070486
Labeler code 84307
Product ID 84307-486_18020632-3cf1-4562-e063-6294a90ab1ad
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler SABIYA, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-20
Substance ZINC OXIDE
Active strength 180 mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 SABIYA Broad Spectrum SPF-50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 180 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z 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 84307-486-00 SABIYA Broad Spectrum SPF-50 100 mL in 1 TUBE CREAM 100 1 84307-486-00 SABIYA Broad Spectrum SPF-50 1 in 1 BOX CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84307-486 SABIYA BROAD SPECTRUM SPF-50 (ZINC OXIDE) CREAM [SABIYA, LLC] 1 Current NDC, 2 package rows 20240520_4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c.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 308 of 353 · 7,041 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84307-486-00 84307048600 1 TUBE in 1 BOX (84307-486-00) / 100 mL in 1 TUBE 1 tube 2024-05-20 No No Current