FDA.reportPublic FDA data

Coola Bare Republic Mineral Body Gel-Lotion

Manufacturer
COOLA LLC
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:18

Label at a glance#

ProductCoola Bare Republic Mineral Body Gel-Lotion SPF 30
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Zinc Oxide 18.2%

OTC - PURPOSE SECTION

Purpose

Suncreen

INDICATIONS & USAGE SECTION

Uses • helps prevent sunburn • if used as directed with other sun protection measures

(see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if skin rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If product is swallowed, get medical help or

contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
● Shake well. Apply liberally 15 minutes before sun exposure
● reapply:
  ● after 40 minutes of swimming or sweating
  ● immediately after towel drying
  ● at least every 2 hours
● Sun Protection Measures. Spending time in the sun
increases your risk of skin cancer and early skin aging. To
decrease this risk, regularly use a sunscreen with a broad
spectrum SPF of 15 or higher and other sun protection
measures including:
  ● limit time in the sun, especially from:
    10 a.m. - 2 p.m.
  ● wear long-sleeve shirts, pants, hats, and sunglasses
● Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Acrylates Copolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, Alpha-Ionone*,
Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Caprylic/capric Triglyceride,
Caprylyl Glycol, Citric Acid, Coccinia Indica Fruit Extract, Corallina Officinalis Extract, Curcuma Longa
(Turmeric) Root Extract, Daucus Carota Sativa (Carrot) Seed Oil, Decanal*, Delta-Dodecalactone*,
Didecyldimonium Chloride, Dimethicone, Dimethyl Heptenal*, Ethyl Ferulate, Gamma-Nonalactone*,
Gamma-Octalactone*, Gamma-Undecalactone*, Glyceryl Stearate SE, Helianthus Annuus (Sunflower)
Seed Oil, 3-Hexenol*, Hexyl Acetate*, Juniperus Virginiana Oil*, Lauryl Glucoside, Melia Azadirachta Flower
Extract, Melia Azadirachta Leaf Extract, Methyl Dihydroabietate, Methlypropanediol, Ocimum Basilicum
(Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Olive Oil Polyglyceryl-6 Esters, Polyacrylate
Crosspolymer-6, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polyquaternium-80, Polysilicone-11,
Propylheptyl Caprylate, Rubus Idaeus (Raspberry) Seed Oil, Solanum Melongena (Eggplant) Fruit Extract,
Sorbitan Stearate, Sorbityl Laurate, Tridecane, Triethoxycaprylylsilane, Triethyl Citrate*, Undecane, Vitis
Vinifera (Grape) Seed Oil, Water, Xanthan Gum


OTHER SAFETY INFORMATION

Other information

  • protect this product from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

Questions or comments?
Call 760-940-2125

COOLA Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF

30

BARE

REPUBLIC

MINERAL

Sunscreen

Non-Nano Zinc Oxide

Gel-Lotion

Sheer, Ultra-Light Hydration

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

4.0 FL OZ / 118 mL

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool

San Diego, CA 92010.

WWW.GOBAREOUTSIDE.COM

042 ltube042 ltube

res

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 55 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-04279753-042-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
ALOE VERA FLOWER575DY8C1ERIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-IONONEI9V075M61RIACT
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCCINIA GRANDIS FRUITVLJ6WOT3K5IACT
CORALLINA OFFICINALIS4004498D06IACT
TURMERIC856YO1Z64FIACT
CARROT SEED OIL595AO13F11IACT
DECANAL31Z90Q7KQJIACT
.DELTA.-DODECALACTONE33DIC582TLIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
DIMETHICONE92RU3N3Y1OIACT
2,6-DIMETHYL-5-HEPTENALZ331YX9EL9IACT
ETHYL FERULATE5B8915UELWIACT
.GAMMA.-NONALACTONEI1XGH66S8PIACT
.GAMMA.-OCTALACTONEUHD6M52X0KIACT
.GAMMA.-UNDECALACTONEQB1T0AG2YLIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
SUNFLOWER OIL3W1JG795YIIACT
3-HEXEN-1-OL, (3Z)-V14F8G75P4IACT
HEXYL ACETATE7U7KU3MWT0IACT
JUNIPERUS VIRGINIANA OILPAD4FN7P2GIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
AZADIRACHTA INDICA FLOWER3TE8A92UPMIACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
OCIMUM BASILICUM FLOWERING TOP7SAB275FP2IACT
HOLY BASIL LEAFSCJ765569PIACT
OLIVE OIL POLYGLYCERYL-6 ESTERS4KDO9AFM9IIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coola Bare Republic Mineral Body Gel-Lotion SPF 30ZINC OXIDE 18.2%COOLA LLCd745d12e-8741-4bf2-89ec-c6f72a8d548b2023-12-20WarningsExact identifier
ndc (package): 79753-042-01
ndc (product): 79753-042
ndc11 (package): 79753004201
spl id: 84b18d74-d0ed-434c-8cf2-75e6a6eb94b8
spl set id: d745d12e-8741-4bf2-89ec-c6f72a8d548b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.