Home NDC 85053-003 WOODSLEEP Tallow Sunscreen
Product NDC 85053-003
11-digit product format 850530003
Labeler code 85053
Product ID 85053-003_448be66c-8d15-e97b-e063-6394a90a4334
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE
Dosage form CREAM
Route TOPICAL
Labeler Shantou Woodsleep Biotechnology Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-28
Substance TALLOW
Active strength .012 mg/60mg
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 WOODSLEEP Tallow Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TALLOW .012 mg/60mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98HPY76U4W 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 85053-003-01 WOODSLEEP Tallow Sunscreen 60 mg in 1 BOX CREAM 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85053-003 WOODSLEEP TALLOW SUNSCREEN (TITANIUM DIOXIDE) CREAM [SHANTOU WOODSLEEP BIOTECHNOLOGY CO., LTD.] 1 Current NDC, 1 package rows 20250429_33cdde09-e7ee-e003-e063-6394a90a8762.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 85053-003-01 85053000301 60 mg in 1 BOX (85053-003-01) 60 mg 2025-04-28 No No Current