Home NDC 71221-333 CoralSafe Broad Spectrum SPF30
Product NDC 71221-333
11-digit product format 712210333
Labeler code 71221
Product ID 71221-333_09d8bb51-cbef-deeb-e063-6394a90a7a60
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE, ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Elements Brands
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-06-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 60; 60 mg/L; mg/L
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 CoralSafe Broad Spectrum SPF30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 60 mg/L ZINC OXIDE 60 mg/L
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71221-333-00 CoralSafe Broad Spectrum SPF30 3.78 L in 1 JUG CREAM 3.78 2 71221-333-00 CoralSafe Broad Spectrum SPF30 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71221-333 CORALSAFE BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ELEMENTS BRANDS] 2 Current NDC, Legacy NDC, 2 package rows 20231111_e6e00896-b7e5-41c6-a72b-08e600758cf5.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 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 UV Defense Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC 365e09a8-308b-b753-e063-6394a90ae9e5 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 71221-333-00 71221033300 1 JUG in 1 CARTON (71221-333-00) / 3.78 L in 1 JUG 1 jug 2018-06-01 0000-00-00 No No Current