Home NDC 54111-188 Performance Face Sunscreen Broad Spectrum
Product NDC 54111-188
11-digit product format 541110188
Labeler code 54111
Product ID 54111-188_94502e3e-fd96-400e-a5ed-4f85ef27fdaf
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Octocrylene, Octisalate
Dosage form CREAM
Route TOPICAL
Labeler Bentley Laboratories, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-18
Substance ZINC OXIDE; OCTOCRYLENE; OCTISALATE
Active strength 9.4; 5; 2 g/100mL; g/100mL; 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 Performance Face Sunscreen Broad Spectrum
Brand name suffix SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 9.4 g/100mL OCTOCRYLENE 5 g/100mL OCTISALATE 2 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 5A68WGF6WM Internal UNII lookup 4X49Y0596W 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 54111-188-30 Performance Face Sunscreen Broad SpectrumSPF 30 30 mL in 1 TUBE CREAM 30 1 54111-188-75 Performance Face Sunscreen Broad SpectrumSPF 30 75 mL in 1 TUBE CREAM 75 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54111-188 PERFORMANCE FACE SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE, OCTOCRYLENE, OCTISALATE) CREAM [BENTLEY LABORATORIES, LLC] 1 Current NDC, 2 package rows 20241208_1629f061-b8fc-4fda-8378-c64e164d41bd.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 54111-188-30 54111018830 30 mL in 1 TUBE (54111-188-30) 30 ml 2023-07-18 No No Current 54111-188-75 54111018875 75 mL in 1 TUBE (54111-188-75) 75 ml 2023-07-18 No No Current