Home NDC 46783-110 Journee Firm Riche Broad Spectrum Sunscreen SPF 30
Product NDC 46783-110
11-digit product format 467830110
Labeler code 46783
Product ID 46783-110_ea56318e-4326-4859-98bf-5344090645bc
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE and ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Merz North America, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-15
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 12.25; 10.2 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Journee Firm Riche Broad Spectrum Sunscreen SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 12.25 mg/mL ZINC OXIDE 10.2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z 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 46783-110-06 Journee Firm Riche Broad Spectrum Sunscreen SPF 30 6 mL in 1 TUBE CREAM 6 3 46783-110-15 Journee Firm Riche Broad Spectrum Sunscreen SPF 30 1 in 1 CARTON CREAM 1 3 46783-110-15 Journee Firm Riche Broad Spectrum Sunscreen SPF 30 15 mL in 1 BOTTLE, PLASTIC CREAM 15 3 46783-110-50 Journee Firm Riche Broad Spectrum Sunscreen SPF 30 50 mL in 1 BOTTLE, PLASTIC CREAM 50 3 46783-110-50 Journee Firm Riche Broad Spectrum Sunscreen SPF 30 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46783-110 JOURNEE FIRM RICHE BROAD SPECTRUM SUNSCREEN SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MERZ NORTH AMERICA, INC.] 2 Current NDC, 5 package rows 20231025_d4d4bfcf-3674-4847-8ad8-1716a8e821ae.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 Marketing end Sample Exclude flag Status 46783-110-06 46783011006 6 mL in 1 TUBE (46783-110-06) 6 ml 2023-03-15 No No Current 46783-110-15 46783011015 1 BOTTLE, PLASTIC in 1 CARTON (46783-110-15) / 15 mL in 1 BOTTLE, PLASTIC 2023-03-15 No No Current 46783-110-50 46783011050 1 BOTTLE, PLASTIC in 1 CARTON (46783-110-50) / 50 mL in 1 BOTTLE, PLASTIC 2023-03-15 2027-04-01 No No Historical