Coola Bare Republic Mineral Body Gel-Lotion

Product NDC
79753-042
11-digit product format
797530042
Labeler code
79753
Product ID
79753-042_84b18d74-d0ed-434c-8cf2-75e6a6eb94b8
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 Body Gel-Lotion
Brand name suffix
SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE18.2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d745d12e-8741-4bf2-89ec-c6f72a8d548bAvailable 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
79753-042-01Coola Bare Republic Mineral Body Gel-LotionSPF 30118 mL in 1 TUBELOTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-042COOLA BARE REPUBLIC MINERAL BODY GEL-LOTION SPF 30 (ZINC OXIDE 18.2%) LOTION [COOLA LLC]2Current NDC, Legacy NDC, 1 package rows20231221_d745d12e-8741-4bf2-89ec-c6f72a8d548b.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 259 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zoey naturals Broad Spectrum SPF 50 Fragrance Free SunscreenZINC OXIDEAbsolutely Natural6e05e060-a531-4c4a-b273-889407ec57042024-12-11WarningsExact identifier
application number: M020
Peptide Lip Shine SPF30 SunscreenZINC OXIDEColorescience, Inc.98cdf19d-8b8a-4051-88bb-79160b2af39e2024-12-11WarningsExact identifier
application number: M020
Zoey naturals Broad Spectrum SPF 50Plus Fragrance Free SunscreenZINC OXIDEAbsolutely Natural082983a4-7b98-489d-8ac2-a185923b86ba2024-12-11WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 50 SunscreenZINC OXIDEAbsolutely Natural89657538-904d-4908-ba7b-6f84706a80012024-12-11WarningsExact identifier
application number: M020
SISLEYA Global Anti-Age Hand care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATEC.F.E.B. Sisleycddf11b1-a89b-4b54-b228-55ba8147f0222024-12-10WarningsExact identifier
application number: M020
SUNLEYA Age minimizing sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley67498d45-0871-4806-8854-81d3e50c4b902024-12-10WarningsExact identifier
application number: M020
SUPER CREME SOLAIRE CORPS Body sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley1c774aa7-8963-4221-b4b0-b894bd1b941f2024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen Cream SPF 30 4-Deep AmberTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley5599922a-b020-477c-a44c-1db42ec5756a2024-12-10WarningsExact identifier
application number: M020
SUNLEYA Age minimizing sun care SPF 50 plusAVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEC.F.E.B. Sisley7c9fadaf-b961-4df0-89ae-87141b50b2c12024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen SPF 30 1-NaturalTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisleyb3d53a10-2647-492a-a05f-b97c3f716aa82024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen SPF 30 2-GoldenTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley389cbce6-552c-4633-babd-7b672632f0b92024-12-10WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC28f08236-1f01-d759-e063-6294a90adcfa2024-12-10WarningsExact identifier
application number: M020
Blistex Five Star Lip Protection Broad SpectrumHOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONEBlistex Inc.47b57317-7df5-442e-a3a4-1d44fe278ac62024-12-10WarningsExact identifier
application number: M020
AHAVA Brightening Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd724bbb91-e273-4926-9ad6-a1657ffe4cd82024-12-10WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d83c576-5dfb-583a-e063-6294a90a2a282024-12-09WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d833e3b-5330-3c5b-e063-6394a90a2ed22024-12-09WarningsExact identifier
application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d9533ba-5606-4116-e063-6294a90ad3b12024-12-09WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d82121d-1dc2-cd99-e063-6394a90aa7662024-12-09WarningsExact identifier
application number: M020
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude310e66a2-8714-4016-87f4-81c1fef19ec92024-12-09WarningsExact identifier
application number: M020
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitudeb6b8733d-6431-4ed2-9350-c63bb901c8042024-12-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-042-0179753004201118 mL in 1 TUBE (79753-042-01) 118 ml2020-03-020000-00-00NoNoCurrent