Home NDC 79753-043 Coola Bare Republic Mineral Face Gel-Lotion
Product NDC 79753-043
11-digit product format 797530043
Labeler code 79753
Product ID 79753-043_fda9b242-5ad3-4e79-90c0-91fa01523771
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE 18.2%
Dosage form LOTION
Route TOPICAL
Labeler COOLA LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-03-02
Substance ZINC OXIDE
Active strength 18.2 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 Gel-Lotion
Brand name suffix SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 18.2 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 79753-043-01 Coola Bare Republic Mineral Face Gel-LotionSPF 30 50 mL in 1 TUBE LOTION 50 2 79753-043-01 Coola Bare Republic Mineral Face Gel-LotionSPF 30 1 in 1 CARTON LOTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-043 COOLA BARE REPUBLIC MINERAL FACE GEL-LOTION SPF 30 (ZINC OXIDE 18.2%) LOTION [COOLA LLC] 2 Current NDC, Legacy NDC, 2 package rows 20231221_ad1614d4-5421-473d-a1e8-0ff18491df77.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 79753-043-01 79753004301 1 TUBE in 1 CARTON (79753-043-01) / 50 mL in 1 TUBE 1 tube 2020-03-02 0000-00-00 No No Current