Home NDC 85163-005 OUHOE Moisturizing And Translucent Sunscreen
Product NDC 85163-005
11-digit product format 851630005
Labeler code 85163
Product ID 85163-005_448df928-432b-6273-e063-6294a90a180d
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE
Dosage form CREAM
Route TOPICAL
Labeler Shantou Ouhoe Technology Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-12
Substance CENTELLA ASIATICA
Active strength .01 mg/50mg
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 OUHOE Moisturizing And Translucent Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CENTELLA ASIATICA .01 mg/50mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7M867G6T1U 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 85163-005-01 OUHOE Moisturizing And Translucent Sunscreen 50 mg in 1 BOX CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85163-005 OUHOE MOISTURIZING AND TRANSLUCENT SUNSCREEN (TITANIUM DIOXIDE) CREAM [SHANTOU OUHOE TECHNOLOGY CO., LTD.] 1 Current NDC, 1 package rows 20250513_34e8e4a6-2782-9a3d-e063-6394a90a84c2.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 85163-005-01 85163000501 50 mg in 1 BOX (85163-005-01) 50 mg 2025-05-12 No No Current