Home NDC 84009-816 SHEER MINERAL SUNSCREEN
Product NDC 84009-816
11-digit product format 840090816
Labeler code 84009
Product ID 84009-816_59a8d775-c366-4056-a985-e80f47f4bfe3
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Plant Devas Inc. dba evanhealy
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-01
Substance ZINC OXIDE
Active strength 20 g/100mL
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 SHEER MINERAL SUNSCREEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20 g/100mL
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 84009-816-01 SHEER MINERAL SUNSCREEN 1 in 1 BOX CREAM 1 2 84009-816-01 SHEER MINERAL SUNSCREEN 60 mL in 1 TUBE CREAM 60 2 84009-816-02 SHEER MINERAL SUNSCREEN 30 mL in 1 BOTTLE, GLASS CREAM 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84009-816 SHEER MINERAL SUNSCREEN (ZINC OXIDE) CREAM [PLANT DEVAS INC. DBA EVANHEALY] 2 Current NDC, 3 package rows 20250406_f620ef44-f30c-4cc9-bc82-28dc4a47a8da.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 238 of 346 · 6,912 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84009-816-01 84009081601 1 TUBE in 1 BOX (84009-816-01) / 60 mL in 1 TUBE 1 tube 2024-03-01 No No Current 84009-816-02 84009081602 30 mL in 1 BOTTLE, GLASS (84009-816-02) 30 ml 2025-04-03 No No Current