Home NDC 83447-005 RENEWALUXE SPF 50 Sunscreen
Product NDC 83447-005
11-digit product format 834470005
Labeler code 83447
Product ID 83447-005_47b31ef5-e027-ed4b-e063-6294a90a2d30
Type HUMAN OTC DRUG
Nonproprietary name RENEWALUXE SPF 50 Sunscreen
Dosage form CREAM
Route CUTANEOUS
Labeler Guangzhou Fantesy Biotechnology Co.,Ltd
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-26
Substance ZINC OXIDE
Active strength 21.8 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 RENEWALUXE SPF 50 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 21.8 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83447-005-01 RENEWALUXE SPF 50 Sunscreen 50 mL in 1 BOX CREAM 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83447-005 RENEWALUXE SPF 50 SUNSCREEN CREAM [GUANGZHOU FANTESY BIOTECHNOLOGY CO.,LTD] 3 Current NDC, 1 package rows 20240810_1bc29960-5e73-e8ab-e063-6294a90a3f80.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 45 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 83447-005-01 83447000501 50 mL in 1 BOX (83447-005-01) 50 ml 2024-06-26 No No Current