Home NDC 79753-041 Coola Bare Republic Mineral Face-Lotion
Product NDC 79753-041
11-digit product format 797530041
Labeler code 79753
Product ID 79753-041_2afb4f90-07f2-4b17-afb2-7d57e211ab6b
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%
Dosage form LOTION
Route TOPICAL
Labeler COOLA LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-05-01
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 15.8; 3.5 g/100mL; g/100mL
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 Coola Bare Republic Mineral Face-Lotion
Brand name suffix SPF 70
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 15.8 g/100mL TITANIUM DIOXIDE 3.5 g/100mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79753-041-01 Coola Bare Republic Mineral Face-LotionSPF 70 59 mL in 1 TUBE LOTION 59 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-041 COOLA BARE REPUBLIC MINERAL FACE-LOTION SPF 70 (TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%) LOTION [COOLA LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231221_a334a61d-5c5a-4f45-b202-6dd7bb3d250b.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 Marketing end Sample Exclude flag Status 79753-041-01 79753004101 59 mL in 1 TUBE (79753-041-01) 59 ml 2020-05-01 0000-00-00 No No Current