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 41 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Light Medium ZINC OXIDE ZO Skin Health, Inc. 4fabe9d0-27fe-230f-e063-6294a90a9ac0 2026-04-17 Warnings Exact identifier application number: M020 ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Medium-Tan ZINC OXIDE ZO Skin Health, Inc. 4fac82b7-d685-2a0d-e063-6394a90aa795 2026-04-17 Warnings Exact identifier application number: M020 SALT WATER VANILLA SUNSCREEN BODY BROAD SPECTRUM SPF 50 SUNSCREEN Saltair Body LLC 4fae649d-f60e-0275-e063-6294a90a1ea5 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEP YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e246e64-2eab-1219-e063-6294a90a79a8 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316cd8a3-3d62-83ac-e063-6394a90a4afa 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e2424f4-0011-42b0-e063-6394a90a780d 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHT YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316cfaea-b71f-2956-e063-6294a90a4f20 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316d1515-6092-a7d6-e063-6394a90ab8b2 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEP YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e246e70-6ec3-5711-e063-6394a90a3879 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e241343-db63-3f1c-e063-6394a90ab538 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316df5fe-0574-d59f-e063-6294a90af8b9 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- SUN GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316c5d69-46f4-7677-e063-6294a90a610f 2026-04-17 Warnings Exact identifier application number: M020 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 PML NYC, LLC 316d905f-232c-d8a2-e063-6394a90adbc9 2026-04-17 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 230 N PML NYC, LLC 316ea01b-4bff-55be-e063-6394a90add94 2026-04-17 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 410 N PML NYC, LLC 316e97bc-4b96-ba6e-e063-6294a90a7648 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c781d7-9d48-892f-e053-2a95a90aca86 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c757b4-6c92-18f0-e053-2a95a90a246d 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c76a82-dc87-35e7-e053-2995a90ae310 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7ac71-3f38-52b2-e053-2a95a90ab54e 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7b929-7492-f072-e053-2995a90a1ca3 2026-04-17 Warnings Exact identifier application number: M020
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