Home NDC 54111-183 Mineral Sunscreen
Product NDC 54111-183
11-digit product format 541110183
Labeler code 54111
Product ID 54111-183_8fbbcad3-e255-4f2a-9902-00f6316a253c
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide Sunscreen
Dosage form CREAM
Route TOPICAL
Labeler Bentley Laboratories LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-12-15
Substance ZINC OXIDE
Active strength 12.025 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 Mineral Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 12.025 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 54111-183-01 Mineral Sunscreen 1 in 1 CARTON CREAM 1 1 54111-183-01 Mineral Sunscreen 42 mL in 1 TUBE CREAM 42 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54111-183 MINERAL SUNSCREEN (ZINC OXIDE SUNSCREEN) CREAM [BENTLEY LABORATORIES LLC] 1 Current NDC, 2 package rows 20241018_782a8641-7e6a-413b-a2ed-0efeb36c48a7.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 54111-183-01 54111018301 1 TUBE in 1 CARTON (54111-183-01) / 42 mL in 1 TUBE 1 tube 2020-12-15 No No Current