Home NDC 54111-166 NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT
Product NDC 54111-166
11-digit product format 541110166
Labeler code 54111
Product ID 54111-166_6c1235b2-ee13-436c-a6fe-05b40bdc8d99
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form LIPSTICK
Route TOPICAL
Labeler Bentley Laboratories, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-12
Substance ZINC OXIDE
Active strength 15 g/100mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 15 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 54111-166-50 NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT 10 mL in 1 TUBE LIPSTICK 10 2 54111-166-50 NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT 1 in 1 CARTON LIPSTICK 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54111-166 NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT (ZINC OXIDE) LIPSTICK [BENTLEY LABORATORIES, LLC] 2 Current NDC, 2 package rows 20241228_6edd51e5-1c42-4e66-b5ca-abfea2dad8f8.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 54111-166-50 54111016650 1 TUBE in 1 CARTON (54111-166-50) / 10 mL in 1 TUBE 1 tube 2023-02-12 No No Current