Home NDC 64127-244 G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN
Product NDC 64127-244
11-digit product format 641270244
Labeler code 64127
Product ID 64127-244_458b7274-da08-6bf7-e063-6394a90a4881
Type HUMAN OTC DRUG
Nonproprietary name zinc oxide, titanium dioxide
Dosage form CREAM
Route TOPICAL
Labeler LABORATOIRES DERMO-COSMETIK INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 8.4; 11.2 g/100g; g/100g
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 G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 8.4 g/100g TITANIUM DIOXIDE 11.2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64127-244-01 G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN 50 g in 1 BOTTLE, PUMP CREAM 50 3 64127-244-01 G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64127-244 G.M. COLLIN FPS-SPF 45 UVA-UVB TINTED SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [LABORATOIRES DERMO-COSMETIK INC.] 2 Current NDC, 2 package rows 20250303_01dcfd14-7a1d-98fa-e063-6294a90a0336.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 81 of 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 64127-244-01 64127024401 1 BOTTLE, PUMP in 1 CARTON (64127-244-01) / 50 g in 1 BOTTLE, PUMP 2024-01-01 No No Current