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 26 of 357 · 7,139 matching rows.
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