Home NDC 64651-7749 Intellishade Original SPF 45
Product NDC 64651-7749
11-digit product format 646517749
Labeler code 64651
Product ID 64651-7749_483911c8-9ba2-d8a0-e063-6394a90a2888
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Revision, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-07-09
Substance OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength 7.5; 5; 3.5; 3 g/100g; g/100g; g/100g; g/100g
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 Intellishade Original SPF 45
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 7.5 g/100g OCTISALATE 5 g/100g TITANIUM DIOXIDE 3.5 g/100g ZINC OXIDE 3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 64651-7749-1 Intellishade Original SPF 45 48 g in 1 TUBE CREAM 48 13 64651-7749-1 Intellishade Original SPF 45 1 in 1 CARTON CREAM 1 13 64651-7749-2 Intellishade Original SPF 45 227 g in 1 TUBE CREAM 227 13 64651-7749-3 Intellishade Original SPF 45 3 g in 1 TUBE CREAM 3 13
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 Marketing end Sample Exclude flag Status 64651-7749-1 64651774901 1 TUBE in 1 CARTON (64651-7749-1) / 48 g in 1 TUBE 1 tube 2013-07-09 0000-00-00 No No Current 64651-7749-2 64651774902 227 g in 1 TUBE (64651-7749-2) 227 g 2013-07-09 0000-00-00 No No Current 64651-7749-3 64651774903 3 g in 1 TUBE (64651-7749-3) 3 g 2013-07-09 0000-00-00 Yes No Current