COOLA BARE REPUBLIC MINERAL FACE GEL-LOTION SPF 30- zinc oxide 18.2% lotion

Coola Bare Republic Mineral Face Gel-Lotion by

Drug Labeling and Warnings

Coola Bare Republic Mineral Face Gel-Lotion by is a Otc medication manufactured, distributed, or labeled by COOLA LLC, Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

Zinc Oxide 18.2%

Purpose

Suncreen

INDICATIONS & USAGE

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

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

KEEP OUT OF REACH OF CHILDREN

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

contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Dimethicone, Propylheptyl
Caprylate, Undecane, Methyl Dihydroabietate,
Polyhydroxystearic Acid, Polymethylsilsesquioxane, Tridecane,
Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis
Flower Extract, Aloe Barbadensis Leaf Juice, Butyrospermum
Parkii (Shea) Butter, Olive Oil Polyclyceryl-6 Esters, Melia
Azadirachta Leaf Extract, Melia Azadirachta Flower Extract,
Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant)
Fruit Extract, Curcuma Longa (Turmeric) Root Extract,
Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum
Santcum Leaf Extract, Juniperus Virginiana Oil, Sorbitan
Stearate, Glyceryl Stearate SE, Polyacrylate Crosspolymer-6,
Xanthan Gum, Acrylates Copolymer, Citric Acid,
Methlpropanediol, Polysilicone-11, Caprylyl Glycol, Glycerin,
Sorbityl Laurate, Plyquaternium-80, Corallina Officinalis
Extract, Ethyl Ferulate, Triethoxycaprylylsilane, Lauryl
Glucoside, Didecyldimonium Chloride, Triethyl Citrate, Hexyl
Acetate, Gamma-Nonalactone, Gamma-Octalactone,
Gamma-Undecalactone, Alpha-Ionone, 3-Hexenol, Dimethyl
Heptenal, Decanal

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

SPF

30

BARE

REPUBLIC

MINERAL

Sunscreen

Non-Nano Zinc Oxide

Face Gel-Lotion

Sheer, Ultra-Light Hydration

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

1.7 FL OZ / 50 mL

©2022 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool

San Diego, CA 92009.

WWW.GOBAREOUTSIDE.COM

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INGREDIENTS AND APPEARANCE

COOLA BARE REPUBLIC MINERAL FACE GEL-LOTION  SPF 30
zinc oxide 18.2% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
UNDECANE (UNII: JV0QT00NUE)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TRIDECANE (UNII: A3LZF0L939)
CUCUMBER (UNII: YY7C30VXJT)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)
EGGPLANT (UNII: W5K7RAS4VK)
TURMERIC (UNII: 856YO1Z64F)
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)
HOLY BASIL LEAF (UNII: SCJ765569P)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITYL LAURATE (UNII: 23XPH3M9LR)
CORALLINA OFFICINALIS (UNII: 4004498D06)
ETHYL FERULATE (UNII: 5B8915UELW)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
HEXYL ACETATE (UNII: 7U7KU3MWT0)
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
.ALPHA.-IONONE (UNII: I9V075M61R)
3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4)
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
DECANAL (UNII: 31Z90Q7KQJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-043-01	1 in 1 CARTON	03/02/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/02/2020

Labeler - COOLA LLC (956990290)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(79753-043)