Home NDC 0316-2046 Blue Lizard Sensitive SPF 50 Sunscreen
Product NDC 0316-2046
11-digit product format 003162046
Labeler code 0316
Product ID 0316-2046_474c85a7-dbae-29f6-e063-6394a90ae5f4
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Crown Laboratories
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-02
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 89.6; 112 mg/mL; mg/mL
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 Blue Lizard Sensitive SPF 50 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 89.6 mg/mL ZINC OXIDE 112 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0316-2046-10 Blue Lizard Sensitive SPF 50 Sunscreen 5 mL in 1 PACKET LOTION 5 6 0316-2046-30 Blue Lizard Sensitive SPF 50 Sunscreen 89 mL in 1 TUBE LOTION 89 6 0316-2046-40 Blue Lizard Sensitive SPF 50 Sunscreen 148 mL in 1 BOTTLE, PLASTIC LOTION 148 6 0316-2046-45 Blue Lizard Sensitive SPF 50 Sunscreen 148 mL in 1 TUBE LOTION 148 6 0316-2046-50 Blue Lizard Sensitive SPF 50 Sunscreen 259 mL in 1 BOTTLE, PLASTIC LOTION 259 6 0316-2046-31 Blue Lizard Sensitive SPF 50 Sunscreen 89 mL in 1 TUBE LOTION 89 3 0316-2046-46 Blue Lizard Sensitive SPF 50 Sunscreen 148 mL in 1 TUBE LOTION 148 3 0316-2046-51 Blue Lizard Sensitive SPF 50 Sunscreen 259 mL in 1 BOTTLE, PLASTIC LOTION 259 3 0316-2046-55 Blue Lizard Sensitive SPF 50 Sunscreen 5 mL in 1 PACKET LOTION 5 3 0316-2046-82 Blue Lizard Sensitive SPF 50 Sunscreen 30 mL in 1 TUBE LOTION 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-2046 BLUE LIZARD SENSITIVE SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES] 4 Current NDC, Legacy NDC, 5 package rows 20231206_9d20b230-2cce-4d90-e053-2995a90a4c03.zip 0316-2046 BLUE LIZARD SENSITIVE SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES] 2 Current NDC, Legacy NDC, 5 package rows 20250525_32d78048-d281-1d80-e063-6394a90aec19.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 Marketing end Sample Exclude flag Status 0316-2046-10 00316204610 5 mL in 1 PACKET (0316-2046-10) 5 ml 2020-03-02 0000-00-00 Yes No Current 0316-2046-30 00316204630 89 mL in 1 TUBE (0316-2046-30) 89 ml 2020-02-17 0000-00-00 No No Current 0316-2046-31 00316204631 89 mL in 1 TUBE (0316-2046-31) 89 ml 2024-12-02 No No Current 0316-2046-40 00316204640 148 mL in 1 BOTTLE, PLASTIC (0316-2046-40) 148 ml 2020-01-29 0000-00-00 No No Current 0316-2046-45 00316204645 148 mL in 1 TUBE (0316-2046-45) 148 ml 2020-02-17 0000-00-00 No No Current 0316-2046-46 00316204646 148 mL in 1 TUBE (0316-2046-46) 148 ml 2024-12-02 No No Current 0316-2046-50 00316204650 259 mL in 1 BOTTLE, PLASTIC (0316-2046-50) 259 ml 2020-02-24 0000-00-00 No No Current 0316-2046-51 00316204651 259 mL in 1 BOTTLE, PLASTIC (0316-2046-51) 259 ml 2025-01-01 No No Current 0316-2046-55 00316204655 5 mL in 1 PACKET (0316-2046-55) 5 ml 2025-02-01 Yes No Current 0316-2046-82 00316204682 30 mL in 1 TUBE (0316-2046-82) 30 ml 2025-12-01 No No Current