Home NDC 0316-2075 Blue Lizard Sport SPF 50 Sunscreen
Product NDC 0316-2075
11-digit product format 003162075
Labeler code 0316
Product ID 0316-2075_50c4e0bf-354b-c1d1-e063-6394a90a8fee
Type HUMAN OTC DRUG
Nonproprietary name Octisalate and Titanium Dioxide and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Crown Laboratories
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-09
Substance OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength 55.5; 59.5; 111 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 OCTISALATE 55.5 mg/mL TITANIUM DIOXIDE 59.5 mg/mL ZINC OXIDE 111 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4X49Y0596W Internal UNII lookup 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0316-2075-30 Blue Lizard Sport SPF 50 Sunscreen 89 mL in 1 TUBE LOTION 89 8 0316-2075-40 Blue Lizard Sport SPF 50 Sunscreen 148 mL in 1 BOTTLE, PLASTIC LOTION 148 8 0316-2075-40 Blue Lizard Sport SPF 50 Sunscreen 1 in 1 CARTON LOTION 1 8 0316-2075-45 Blue Lizard Sport SPF 50 Sunscreen 148 mL in 1 TUBE LOTION 148 8 0316-2075-50 Blue Lizard Sport SPF 50 Sunscreen 259 mL in 1 BOTTLE, PLASTIC LOTION 259 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-2075 BLUE LIZARD SPORT SPF 50 SUNSCREEN (OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES] 4 Current NDC, Legacy NDC, 5 package rows 20231205_4955fa1c-789d-4f42-af75-70223310644a.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 0316-2075-30 00316207530 89 mL in 1 TUBE (0316-2075-30) 89 ml 2021-02-09 0000-00-00 No No Current 0316-2075-40 00316207540 1 BOTTLE, PLASTIC in 1 CARTON (0316-2075-40) > 148 mL in 1 BOTTLE, PLASTIC 2021-03-04 0000-00-00 No No Current 0316-2075-45 00316207545 148 mL in 1 TUBE (0316-2075-45) 148 ml 2021-05-01 0000-00-00 No No Current 0316-2075-50 00316207550 259 mL in 1 BOTTLE, PLASTIC (0316-2075-50) 259 ml 2021-05-01 0000-00-00 No No Current