Home NDC 54111-190 111 SKIN SUNSCREEN SPF 50
Product NDC 54111-190
11-digit product format 541110190
Labeler code 54111
Product ID 54111-190_3885e519-7eb8-4b06-97fe-85471b0e6951
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form SOLUTION
Route TOPICAL
Labeler Bentley Laboratories, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-23
Substance ZINC OXIDE
Active strength 19.5 g/100mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 111 SKIN SUNSCREEN SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 19.5 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 54111-190-01 111 SKIN SUNSCREEN SPF 50 50 mL in 1 BOTTLE, PUMP SOLUTION 50 2 54111-190-01 111 SKIN SUNSCREEN SPF 50 1 in 1 CARTON SOLUTION 1 2 54111-190-02 111 SKIN SUNSCREEN SPF 50 15 mL in 1 BOTTLE, PUMP SOLUTION 15 2 54111-190-02 111 SKIN SUNSCREEN SPF 50 1 in 1 CARTON SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54111-190 111 SKIN SUNSCREEN SPF 50 (ZINC OXIDE) SOLUTION [BENTLEY LABORATORIES, LLC] 1 Current NDC, 4 package rows 20250523_b1265797-71dd-4302-ab26-dbff6ccec856.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 Marketing start Sample Exclude flag Status 54111-190-01 54111019001 1 BOTTLE, PUMP in 1 CARTON (54111-190-01) / 50 mL in 1 BOTTLE, PUMP 2025-05-23 No No Current 54111-190-02 54111019002 1 BOTTLE, PUMP in 1 CARTON (54111-190-02) / 15 mL in 1 BOTTLE, PUMP 2026-05-01 No No Current