Home NDC 84066-104 SPF 50 MINERAL SUNSCREEN LIP
Product NDC 84066-104
11-digit product format 840660104
Labeler code 84066
Product ID 84066-104_46872f1f-b25a-abbb-e063-6394a90a0e8f
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide , Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Guangzhou Tata Biotechnology Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-03
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 4.85; 8 mg/100mL; 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 SPF 50 MINERAL SUNSCREEN LIP
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 4.85 mg/100mL TITANIUM DIOXIDE 8 mg/100mL
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 84066-104-01 SPF 50 MINERAL SUNSCREEN LIP 29.6 mL in 1 BOTTLE CREAM 29.6 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84066-104 SPF 50 MINERAL SUNSCREEN LIP (ZINC OXIDE , TITANIUM DIOXIDE) CREAM [GUANGZHOU TATA BIOTECHNOLOGY CO., LTD.] 1 Current NDC, 1 package rows 20240718_1c6f0964-9bee-1c06-e063-6294a90ac2a4.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 84066-104-01 84066010401 29.6 mL in 1 BOTTLE (84066-104-01) 29.6 ml 2024-07-03 No No Current