FDA.reportPublic FDA data

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 273 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bali Body Cacao Tanning Oil SPF 15OCTOCRYLENE, OCTISALATE, AVOBENZONEBali Body Pty Ltd03c0b83d-0d85-9e69-e063-6394a90a61422024-10-21WarningsExact identifier
application number: M020
ALDI LACURA KIDS SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCe34f37d7-02a5-0b72-e053-2a95a90acf832024-10-21WarningsExact identifier
application number: M020
Aldi Lacura Ultra Light Body SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEALDI INCf7ac082c-def8-4379-e053-6294a90a57e32024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Sport Sunscreen 30 Broad Spectrum SPF 30 ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCf7bdc1f7-d961-4596-e053-6394a90a1d872024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Ultra Light Dry-Touch 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEALDI INCf7b2cf4e-468c-3406-e053-6394a90a21392024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Sport Sunscreen 50 Broad Spectrum SPF 50 ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCf7b32aa8-2e56-3725-e053-6294a90a18d22024-10-21WarningsExact identifier
application number: M020
Bliss Block Star Sheer Liquid Daily Sunscreen SPF 50 SPF-50ZINC OXIDEBliss Products Holdings LLCf262e5a7-3c57-a6d8-e053-2995a90aacbc2024-10-21WarningsExact identifier
application number: M020
Berkley Jensen Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBJWCfbd65277-7aff-de19-e053-6394a90a94962024-10-21WarningsExact identifier
application number: M020
Sun Bum SPF 15 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC01bfe44c-655f-404c-981e-8d5f6728a7382024-10-21WarningsExact identifier
application number: M020
Sun Bum SPF 70 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLCaa612570-b70a-4910-8086-6634834beb702024-10-21WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLCf5bd673a-46e5-43d5-9d76-8ddc5da701462024-10-21WarningsExact identifier
application number: M020
Sun Bum Kids Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLC6fcec9f9-bee0-4884-8c72-be273426f9162024-10-21WarningsExact identifier
application number: M020
sunscreenSKIN BARRIER SUN SHIELD SPF 30True Botanicals, Inc.d70eea23-7715-c17b-e053-2a95a90a839f2024-10-18WarningsExact identifier
application number: M020
First Aid Only SunX30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcme United Corporation24c22903-8911-81d9-e063-6394a90a108b2024-10-18WarningsExact identifier
application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD33f8760c-2953-44a6-9239-424fdb97a5b32024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c85e5094-d442-55a9-e053-2995a90aed122024-10-18WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.24c78897-3136-f24b-e063-6394a90aa80a2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f42a0b1e-038d-4fab-e053-2995a90a53642024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Manuka Honey and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f451c472-1d9f-1fbc-e053-2995a90a114e2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenZINC OXIDEFruit Of The Earth, Inc.f4490608-6cce-90f3-e053-2995a90a49302024-10-18WarningsExact 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