FDA.reportPublic FDA data

Coola Bare Republic Mineral Face-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 00:05:13

Label at a glance#

ProductCoola Bare Republic Mineral Face-Lotion SPF 70
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Titanium Dioxide 3.5%

Zinc Oxide 15.8%

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 80
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
Allyl Heptoate, Alumina, Benzyl Alcohol,
Butyrospermum Parkii (Shea) Butter, C20-22
Alcohols, C20-22 Alkyl Phosphate, Calcium
Starch Octenylsuccinate, Caprylhydroxamic
Acid, Caprylic/Capric Triglyceride, Caprylyl
Glycol, Cellulose Gum, Cetearyl Alcohol,
Coco-Caprylate/Caprate, Coco-Glucoside,
Daucus Carota Sativa (Carrot) Root Extract,
Dimethicone, Ethylhexyl Methoxycrylene,
Gamma-Decalactone, Gamma-Nonalactone,
Gamma-Octalactone, Glycerin, Heliotropine,
1,2-Hexanediol, Isostearic Acid, Lauryl Laurate,
Lecithin, Methyl Dihydroabietate,
Microcrystalline Cellulose, Polyglyceryl-3
Polyricinoleate, Polyhydroxystearic Acid,
Raspberry Ketone, Rubus Idaeus (Raspberry)
Leaf Extract, Sodium Hydroxide, Sodium
Phytate, Stearic Acid, Stearyl/Octyldodecyl
Citrate Crosspolymer, Triethyl Citrate, Vanillin,
Vitis Vinifera (Grape) Seed Extract, Water


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

70

BARE

REPUBLIC

MINERAL

Sunscreen Lotion

Non-Nano Zinc Oxide

Face

Sheer, Oil-Free Finish

Broad Spectrum SPF 70

Water Resistant (80 Minutes)

2.0 FL OZ / 59 mL

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

San Diego, CA 92010.

041-01041-01

041-01 Tube041-01 Tube

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
79753-041-01Coola 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

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-04179753-041-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALLYL HEPTANOATEAU4CYG9V68IACT
BENZYL ALCOHOLLKG8494WBHIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
C20-22 ALCOHOLSO4M0347C6AIACT
C20-22 ALKYL PHOSPHATEL4VKP0Y7RPIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
COCO GLUCOSIDEICS790225BIACT
CARROTL56Z1JK48BIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
.GAMMA.-DECALACTONE7HLS05KP9OIACT
.GAMMA.-NONALACTONEI1XGH66S8PIACT
.GAMMA.-OCTALACTONEUHD6M52X0KIACT
GLYCERINPDC6A3C0OXIACT
PIPERONALKE109YAK00IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ISOSTEARIC ACIDX33R8U0062IACT
LAURYL LAURATEGPW77G0937IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
4-(P-HYDROXYPHENYL)-2-BUTANONE7QY1MH15BGIACT
RUBUS IDAEUS LEAF8O2V33JG64IACT
SODIUM HYDROXIDE55X04QC32IIACT
DISODIUM PHTHALATEQB14YV193CIACT
STEARIC ACID4ELV7Z65APIACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
VANILLINCHI530446XIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
WATER059QF0KO0RIACT

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 Face-Lotion SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%COOLA LLCa334a61d-5c5a-4f45-b202-6dd7bb3d250b2023-12-20WarningsExact identifier
ndc (package): 79753-041-01
ndc (product): 79753-041
ndc11 (package): 79753004101
spl id: 2afb4f90-07f2-4b17-afb2-7d57e211ab6b
spl set id: a334a61d-5c5a-4f45-b202-6dd7bb3d250b

Reported adverse events (FAERS/openFDA)#

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