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 304 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BB Tint 30 BS SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs1212448c-db88-26e6-e063-6294a90a3b9e2024-02-23WarningsExact identifier
application number: M020
Daily Prevention Pure Mineral Hydrating Moisturizer SPF30ZINC OXIDEAllure Labs11fce5ec-66e8-9eac-e063-6394a90aaf3a2024-02-22WarningsExact identifier
application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -DEEPHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarinsbf31d19d-9520-4ac0-a4fd-2c285545f1b82024-02-20WarningsExact identifier
application number: M020
Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint MediumHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins2c0964cd-607c-4219-b66e-cc99ada804342024-02-20WarningsExact identifier
application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -LIGHTHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins6259442e-0c39-4887-8083-89253b64b5ff2024-02-20WarningsExact identifier
application number: M020
Meijer SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCSTISALATE 5%, OCTOCRYLENE 6%Meijer074b6340-0482-ab05-e063-6294a90adedb2024-02-19WarningsExact identifier
application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.11c37acc-abb8-8c38-e063-6294a90a79322024-02-19WarningsExact identifier
application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltd11c461f7-0f34-65ff-e063-6294a90a3da72024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.11c61b92-89f4-692f-e063-6394a90a69cd2024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd11c651e2-072e-770e-e063-6394a90ad6fa2024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.11c65e7f-fe11-8115-e063-6394a90a85942024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd11c6cf95-8923-af79-e063-6294a90a4f442024-02-19WarningsExact identifier
application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.118842ce-9d9b-80ce-e063-6394a90ab9862024-02-16WarningsExact identifier
application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd11894c1d-c199-dfc0-e063-6394a90a3f152024-02-16WarningsExact identifier
application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.711aa92c-81b0-42e4-b83f-9ce95116ec032024-02-16WarningsExact identifier
application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b8bc0021-bb4d-45f2-a570-3f2e61edf21d2024-02-16WarningsExact identifier
application number: M020
Meijer SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Meijer075dddd5-46ea-282a-e063-6294a90a28fd2024-02-15WarningsExact identifier
application number: M020
Sheet SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma Inc.bbb5b87c-d641-3ba2-e053-2a95a90a0f702024-02-14WarningsExact identifier
application number: M020
sheer tint SPF 45BROAD SPECTRUMCP Skin Health Group, Inc.b7c5cedd-ff68-74de-e053-2a95a90a37962024-02-14WarningsExact identifier
application number: M020
Weightless Protection SPF 45SUNSCREEN BROAD SPECTRUMCP Skin Health Group, Inc.b6bee26d-bffd-a8ee-e053-2a95a90affc52024-02-14WarningsExact 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