Home NDC 51326-201 Replenix Tinted Sunscreen
Product NDC 51326-201
11-digit product format 513260201
Labeler code 51326
Product ID 51326-201_d4677ccd-57aa-437f-b862-58bb18b80028
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide and Octinoxate
Dosage form LOTION
Route TOPICAL
Labeler Topiderm, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-22
Substance ZINC OXIDE; OCTINOXATE
Active strength 145; 75 mg/g; mg/g
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 Replenix Tinted Sunscreen
Brand name suffix SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 145 mg/g OCTINOXATE 75 mg/g
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 4Y5P7MUD51 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 51326-201-01 Replenix Tinted Sunscreen SPF 50 63 g in 1 BOTTLE LOTION 63 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51326-201 REPLENIX TINTED SUNSCREEN SPF 50 (ZINC OXIDE AND OCTINOXATE) LOTION [TOPIDERM, INC.] 3 Current NDC, 1 package rows 20241013_1fda4a54-e323-4f3c-b659-bded4b1b3dd0.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 51326-201-01 51326020101 63 g in 1 BOTTLE (51326-201-01) 63 g 2022-04-22 No No Current