Home NDC 79753-029 COOLA BARE REPUBLIC MINERAL SPORT SPF50
Product NDC 79753-029
11-digit product format 797530029
Labeler code 79753
Product ID 79753-029_45edb38b-e49e-d95f-e063-6394a90ad93c
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler COOLA, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-01
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 78; 29 mg/mL; mg/mL
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 COOLA BARE REPUBLIC MINERAL SPORT SPF50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 78 mg/mL TITANIUM DIOXIDE 29 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79753-029-71 COOLA BARE REPUBLIC MINERAL SPORT SPF50 148 mL in 1 BOTTLE LOTION 148 3 79753-029-72 COOLA BARE REPUBLIC MINERAL SPORT SPF50 946 mL in 1 BOTTLE LOTION 946 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-029 COOLA BARE REPUBLIC MINERAL SPORT SPF50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [COOLA, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20241025_bbf15e58-c160-d599-e053-2a95a90a0696.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 353 · 7,049 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 79753-029-71 79753002971 148 mL in 1 BOTTLE (79753-029-71) 148 ml 2018-11-01 0000-00-00 No No Current 79753-029-72 79753002972 946 mL in 1 BOTTLE (79753-029-72) 946 ml 2018-11-01 0000-00-00 No No Current