Home NDC 85163-012 OUHOE Tinted Sunscreen
Product NDC 85163-012
11-digit product format 851630012
Labeler code 85163
Product ID 85163-012_4540f542-248e-bcf5-e063-6294a90aabca
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 2025-12-06
Substance CITRUS JUNOS FRUIT
Active strength .008 mg/40mg
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 Tinted Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CITRUS JUNOS FRUIT .008 mg/40mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 53KHW58C1V 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 85163-012-01 OUHOE Tinted Sunscreen 40 mg in 1 BOTTLE, PLASTIC CREAM 40 1
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 85163-012-01 85163001201 40 mg in 1 BOTTLE, PLASTIC (85163-012-01) 40 mg 2025-12-06 No No Current