Home NDC 0316-2078 Blue Lizard Sport SPF 50 Sunscreen
Product NDC 0316-2078
11-digit product format 003162078
Labeler code 0316
Product ID 0316-2078_4834a81b-775d-26aa-e063-6294a90a206d
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 Sport 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0316-2078-30 Blue Lizard Sport SPF 50 Sunscreen 89 mL in 1 TUBE LOTION 89 2 0316-2078-35 Blue Lizard Sport SPF 50 Sunscreen 148 mL in 1 TUBE LOTION 148 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-2078 BLUE LIZARD SPORT SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES] 1 Current NDC, 2 package rows 20250420_2f3844d8-0367-aad9-e063-6294a90a1fce.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 Units Marketing start Sample Exclude flag Status 0316-2078-30 00316207830 89 mL in 1 TUBE (0316-2078-30) 89 ml 2024-12-02 No No Current 0316-2078-35 00316207835 148 mL in 1 TUBE (0316-2078-35) 148 ml 2024-12-02 No No Current