Home NDC 87283-003 ROE WELLNESS SPF 50 MINERAL
Product NDC 87283-003
11-digit product format 872830003
Labeler code 87283
Product ID 87283-003_47dc8155-4abc-4bb7-e063-6294a90af1ad
Type HUMAN OTC DRUG
Nonproprietary name spf 50 mineral powder
Dosage form POWDER
Route TOPICAL
Labeler Aopline Biotechnology (Guangzhou) Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-08
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 24.1; 23.9 g/100g; g/100g
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 ROE WELLNESS SPF 50 MINERAL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 24.1 g/100g TITANIUM DIOXIDE 23.9 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 15FIX9V2JP 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 87283-003-01 ROE WELLNESS SPF 50 MINERAL 6 g in 1 BOX POWDER 6 1
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 87283-003-01 87283000301 6 g in 1 BOX (87283-003-01) 6 g 2026-01-08 No No Current