FDA.reportPublic FDA data

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
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
3.5; 15.8 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

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
IngredientStrength
ZINC OXIDE15.8 g/100mL
TITANIUM DIOXIDE3.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a334a61d-5c5a-4f45-b202-6dd7bb3d250bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-041-01Coola Bare Republic Mineral Face-LotionSPF 7059 mL in 1 TUBELOTION592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-041COOLA BARE REPUBLIC MINERAL FACE-LOTION SPF 70 (TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%) LOTION [COOLA LLC]2Current NDC, Legacy NDC, 1 package rows20231221_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 1 of 361 · 7,215 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
application number: M020
Juyasuyon Sport Ultra Sunscreen CreamOCTOCRYLENE,OXYBENZONE,AVOBENZONE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangdong Aimu Biological Technology Co., Ltd598cfe9e-6ebe-ad18-e063-6294a90ace222026-08-25WarningsExact identifier
application number: M020
NeoStrata Sheer Hydration Sunscreen Broad Spectrum SPF 40OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.e8cdf9f7-d968-42b3-bcb8-02dee7717fd82026-08-25WarningsExact identifier
application number: M020
JUYASUYON Sport Ultra SunscreenAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGuangdong Aimu Biological Technology Co., Ltd59d97ee0-e416-53e7-e063-6294a90a91532026-08-25WarningsExact identifier
application number: M020
NeoStrata Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.ed495f18-2f8e-4991-b797-82e9f6fc7acb2026-08-25WarningsExact identifier
application number: M020
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.59e9279a-2427-d6bc-e063-6394a90ae86e2026-08-25WarningsExact identifier
application number: M020
Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.4739e678-ce51-4863-bb74-2275879e1b472026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(YELLOW)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c3009b-ae16-52e1-e063-6394a90a69ee2026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(PINK)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c68d9b-9aa9-4996-e063-6394a90a48d42026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(BLUE)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c78929-9df7-5212-e063-6394a90a37662026-08-24WarningsExact identifier
application number: M020
Dr Marvel COLOR CHANGING FOUNDATION SPF30ETHYLHEXYL METHOXYCINNAMATEGuangzhou Liyan Cosmetics Technology Co., Ltd.59c8865f-ccee-dd50-e063-6294a90aa1852026-08-24WarningsExact identifier
application number: M020
Exuviance Daily Corrector with Sunsreen Broad Spectrum SPF 35OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.74a998e2-8ebf-436c-aac1-b456cd2e072d2026-08-24WarningsExact identifier
application number: M020
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDEAldi Inc59cbfb14-d9b1-ce93-e063-6394a90ac3122026-08-24Warnings, Adverse reactionsExact identifier
application number: M020
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.59ac747a-f9c7-2c18-e063-6394a90a23062026-08-23WarningsExact identifier
application number: M020
Sunski Sol Power Daily Face Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLCb6c3d6b1-3d8a-43c0-aac5-07fe60afbd8c2026-08-21WarningsExact identifier
application number: M020
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-08-21WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC5990fe66-4fa2-06aa-e063-6294a90a52612026-08-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-041-017975300410159 mL in 1 TUBE (79753-041-01) 59 ml2020-05-010000-00-00NoNoCurrent