Home NDC 51326-122 Essential Moisturizing Sunscreen
Product NDC 51326-122
11-digit product format 513260122
Labeler code 51326
Product ID 51326-122_5fc4712e-bf0a-49e6-84e7-049b81f7b440
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Octinoxate
Dosage form LOTION
Route TOPICAL
Labeler Topiderm, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-09
Substance ZINC OXIDE; OCTINOXATE
Active strength 148; 75 mg/g; mg/g
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 Essential Moisturizing Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 148 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 51326-122-20 Essential Moisturizing Sunscreen 63 g in 1 BOTTLE, PLASTIC LOTION 63 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51326-122 ESSENTIAL MOISTURIZING SUNSCREEN (ZINC OXIDE, OCTINOXATE) LOTION [TOPIDERM, INC.] 4 Current NDC, 1 package rows 20241022_450d916e-4c77-489e-86b1-78b686355476.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 27 of 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51326-122-20 51326012220 63 g in 1 BOTTLE, PLASTIC (51326-122-20) 63 g 2021-01-09 No No Current