Home NDC 72043-2630 EltaMD UV Restore
Product NDC 72043-2630
11-digit product format 720432630
Labeler code 72043
Product ID 72043-2630_d0f9434f-9396-4f8c-a985-b0296bff76f1
Type HUMAN OTC DRUG
Nonproprietary name titanium dioxide, zinc oxide sunscreen
Dosage form LOTION
Route TOPICAL
Labeler CP Skin Health Group, Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-01
Marketing end 2027-08-31
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 20; 150 g/1000g; g/1000g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
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 EltaMD UV Restore Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 20 g/1000g ZINC OXIDE 150 g/1000g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72043-2630-1 EltaMD UV Restore 48 g in 1 BOTTLE LOTION 48 5 72043-2630-2 EltaMD UV Restore 57 g in 1 TUBE LOTION 57 5 72043-2630-4 EltaMD UV Restore 2 g in 1 PACKET LOTION 2 5 72043-2630-5 EltaMD UV Restore 14 g in 1 BOTTLE LOTION 14 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72043-2630 ELTAMD UV RESTORE (TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN) LOTION [CP SKIN HEALTH GROUP, INC] 5 Current NDC, Legacy NDC, 4 package rows 20231110_37fee381-ce6b-4949-9a4a-778aa839fb84.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 72043-2630-1 72043263001 48 g in 1 BOTTLE (72043-2630-1) 48 g 2023-11-09 2027-04-30 No No Historical 72043-2630-2 72043263002 57 g in 1 TUBE (72043-2630-2) 57 g 2020-10-01 2026-10-30 No No Current 72043-2630-4 72043263004 2 g in 1 PACKET (72043-2630-4) 2 g 2020-10-01 0000-00-00 No No Current 72043-2630-5 72043263005 14 g in 1 BOTTLE (72043-2630-5) 14 g 2020-10-01 2027-08-31 No No Current