Home NDC 83566-100 GZE Tinted Sunscreen
Product NDC 83566-100
11-digit product format 835660100
Labeler code 83566
Product ID 83566-100_39f072dd-c171-0c1f-e063-6294a90afb9d
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide 3%
Dosage form CREAM
Route TOPICAL
Labeler Guangzhou Yilong Cosmetics Co.,Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-07
Substance ZINC OXIDE
Active strength 3 mg/100mL
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 GZE Tinted Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 3 mg/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 83566-100-01 GZE Tinted Sunscreen 40 mL in 1 TUBE CREAM 40 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83566-100 GZE TINTED SUNSCREEN (ZINC OXIDE 3%) CREAM [GUANGZHOU YILONG COSMETICS CO.,LTD.] 2 Current NDC, 1 package rows 20240606_182612d8-76a4-44a1-e063-6394a90a8d5f.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 Sample Exclude flag Status 83566-100-01 83566010001 40 mL in 1 TUBE (83566-100-01) 40 ml 2023-07-07 No No Current