Home NDC 0316-2045 Blue Lizard Sensitive Sunscreen
Product NDC 0316-2045
11-digit product format 003162045
Labeler code 0316
Product ID 0316-2045_48345730-de18-7fb2-e063-6394a90a9b5d
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 2003-12-08
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 54; 108 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 · 35 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 Sensitive Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 54 mg/mL ZINC OXIDE 108 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 0316-2045-10 Blue Lizard Sensitive Sunscreen 5 mL in 1 PACKET LOTION 5 19 0316-2045-30 Blue Lizard Sensitive Sunscreen 89 mL in 1 TUBE LOTION 89 19 0316-2045-40 Blue Lizard Sensitive Sunscreen 148 mL in 1 BOTTLE, PLASTIC LOTION 148 19 0316-2045-45 Blue Lizard Sensitive Sunscreen 148 mL in 1 TUBE LOTION 148 19 0316-2045-50 Blue Lizard Sensitive Sunscreen 259 mL in 1 BOTTLE, PLASTIC LOTION 259 19 0316-2045-60 Blue Lizard Sensitive Sunscreen 3785 mL in 1 JUG LOTION 3785 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-2045 BLUE LIZARD SENSITIVE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES] 17 Current NDC, Legacy NDC, 6 package rows 20241127_1e4d49f4-9e77-48b5-bce5-ff04ed885a0f.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 112 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Mineral Sunscreen ZINC OXIDE Natur LLC 365f3c48-15a6-2d32-e063-6394a90aad78 2025-12-16 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE Natur LLC 365fffa2-b846-7dd3-e063-6394a90a47cb 2025-12-16 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Natur LLC 36603550-9c3d-5e33-e063-6394a90adfc9 2025-12-16 Exact identifier application number: M020 Shield And Protect Tinted ZINC OXIDE TRILOGY LABORATORIES, LLC 37f00e51-1123-c04c-e063-6294a90abed8 2025-12-16 Exact identifier application number: M020 Shield And Protect ZINC OXIDE TRILOGY LABORATORIES, LLC 37f09dd5-084f-3c80-e063-6394a90a7a53 2025-12-16 Exact identifier application number: M020 Non Tinted Facial Mineral Protectant TITANIUM DIOXIDE, ZINC OXIDE EUROPEAN SKIN AND MASSAGE STUDIO 3766496f-231c-f98c-e063-6294a90aae08 2025-12-16 Exact identifier application number: M020 Tinted Facial Mineral Protectant TITANIUM DIOXIDE, ZINC OXIDE EUROPEAN SKIN AND MASSAGE STUDIO 3766b0d8-20e6-a227-e063-6294a90af4da 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 37515807-e29a-3916-e063-6394a90a1ffd 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen Broad Spectrum SPF 40 TITANIUM DIOXIDE, ZINC OXIDE WECARE FRISCO PLLC 374f866d-eb52-61e3-e063-6394a90a77c7 2025-12-16 Exact identifier application number: M020 Tinted Lip Protection TITANIUM DIOXIDE, ZINC OXIDE WECARE FRISCO PLLC 3750c23d-c3f8-fac3-e063-6394a90a135e 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40 ZINC OXIDE WECARE FRISCO PLLC 374fe86e-cbe8-f911-e063-6294a90a9600 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 37507b14-fc01-5e27-e063-6294a90afd50 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 375203a6-2ab8-2a80-e063-6294a90ada72 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 3751caa3-867e-5901-e063-6294a90ab6bd 2025-12-16 Exact identifier application number: M020 Auset Tinted Replenishing Daily Protection ZINC OXIDE SHAYLA BOGER SKIN THERAPY LLC 37da48d6-8f12-ec97-e063-6294a90a699c 2025-12-16 Exact identifier application number: M020 Morning Replenish ZINC OXIDE KATHY JONES AESTHETHICS LLC 37da711e-840b-2f2a-e063-6294a90ab16c 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE KATHY JONES AESTHETHICS LLC 37dab729-5988-5eba-e063-6294a90ac6b7 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tory Sullivan, M.D., P.A. 36241e60-f02a-50a7-e063-6394a90a6390 2025-12-16 Exact identifier application number: M020 Ageless All Fitz ZINC OXIDE A.Wall Beauty LLC 37670cb1-ac75-5049-e063-6394a90a4d0a 2025-12-16 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Tory Sullivan, M.D., P.A. 36244b27-20e5-f370-e063-6294a90a1f6c 2025-12-16 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0316-2045-10 00316204510 5 mL in 1 PACKET (0316-2045-10) 5 ml 2004-04-01 0000-00-00 No No Current 0316-2045-30 00316204530 89 mL in 1 TUBE (0316-2045-30) 89 ml 2006-01-03 0000-00-00 No No Current 0316-2045-40 00316204540 148 mL in 1 BOTTLE, PLASTIC (0316-2045-40) 148 ml 2003-12-08 0000-00-00 No No Current 0316-2045-45 00316204545 148 mL in 1 TUBE (0316-2045-45) 148 ml 2019-01-02 0000-00-00 No No Current 0316-2045-50 00316204550 259 mL in 1 BOTTLE, PLASTIC (0316-2045-50) 259 ml 2005-01-03 0000-00-00 No No Current 0316-2045-60 00316204560 3785 mL in 1 JUG (0316-2045-60) 3785 ml 2004-02-02 0000-00-00 No No Current