Home NDC 80325-030 MACKENZIES OCEAN SAFE SUNSCREEN
Product NDC 80325-030
11-digit product format 803250030
Labeler code 80325
Product ID 80325-030_1fd0a790-c66d-216f-e063-6294a90ae971
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Naturally Uncommon, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-01
Substance TITANIUM DIOXIDE
Active strength 8.8 g/100mL
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 MACKENZIES OCEAN SAFE SUNSCREEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 8.8 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP 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 80325-030-03 MACKENZIES OCEAN SAFE SUNSCREEN 88 mL in 1 TUBE CREAM 88 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80325-030 MACKENZIES OCEAN SAFE SUNSCREEN (TITANIUM DIOXIDE) CREAM [NATURALLY UNCOMMON, LLC] 1 Current NDC, 1 package rows 20240817_1fd0a790-c66c-216f-e063-6294a90ae971.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 138 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daily Moisturizing Glow Sunscreen Cream ZINC OXIDE Shelley Bennett Skincare 326e49b8-e21c-0df0-e063-6394a90a2ebc 2025-12-10 Exact identifier application number: M020 Daily Moisturizing Glow Sunscreen Cream ZINC OXIDE SHELLEY BENNET SKINCARE 325df1f8-1678-c07c-e063-6294a90a96fb 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bafa0b-d253-c263-e063-6394a90ad1e4 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35ba578f-a842-7eec-e063-6394a90a1165 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen Zinc Oxide ZINC OXIDE Hirschman, Kristina 35bb3b36-3886-ea8e-e063-6394a90a5257 2025-12-10 Exact identifier application number: M020 Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bc3994-1f72-2bbf-e063-6294a90ac2f1 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bccadf-6fc8-abd0-e063-6294a90aaa2e 2025-12-10 Exact identifier application number: M020 Mineral Sunscreen Zinc Oxide ZINC OXIDE Hirschman, Kristina 35bb9341-355f-4910-e063-6294a90a8c15 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bd61ff-0d66-a9b3-e063-6394a90ad940 2025-12-10 Exact identifier application number: M020 SHADED TITANIUM DIOXIDE, ZINC OXIDE Potency No. 710 LLC 31177bbd-68b0-8b24-e063-6294a90aa8d8 2025-12-10 Warnings Exact identifier application number: M020 SHADED TITANIUM DIOXIDE, ZINC OXIDE Potency No. 710 LLC 3117e138-83a1-0931-e063-6394a90abe43 2025-12-10 Warnings Exact identifier application number: M020 SHADED TITANIUM DIOXIDE, ZINC OXIDE Potency No. 710 LLC 31188175-a4ca-449f-e063-6394a90a3c05 2025-12-10 Warnings Exact identifier application number: M020 COVERED ZINC OXIDE Potency No. 710 LLC 3118c3ed-f0f0-f997-e063-6294a90a53a9 2025-12-10 Warnings Exact identifier application number: M020 COVERED ZINC OXIDE Potency No. 710 LLC 3117faeb-1792-1b2e-e063-6294a90a92df 2025-12-10 Warnings Exact identifier application number: M020 Non-Tinted Mineral Foaming Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Restore Skin Therapy, LLC 364b6af2-a0ed-4a17-e063-6394a90a3a17 2025-12-10 Exact identifier application number: M020 Morning Replenish ZINC OXIDE Restore Skin Therapy, LLC 364b26c2-a1bb-9660-e063-6294a90a14d1 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Tinted ZINC OXIDE Fleur de Lune, LLC 34288989-35b8-3aa3-e063-6394a90ac2c4 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Tinted ZINC OXIDE Fleur de Lune, LLC 3418394b-fede-65ce-e063-6394a90ad5f9 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Non-Tinted ZINC OXIDE Fleur de Lune, LLC 341871e5-c170-7560-e063-6394a90a8eee 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Non-Tinted ZINC OXIDE Fleur de Lune, LLC 3428bdbb-1f18-a29b-e063-6294a90addbc 2025-12-10 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80325-030-03 80325003003 88 mL in 1 TUBE (80325-030-03) 88 ml 2022-07-01 No No Current