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

Coola Bare Republic Mineral Body Gel-Lotion by

Drug Labeling and Warnings

Coola Bare Republic Mineral Body Gel-Lotion by is a Otc medication manufactured, distributed, or labeled by COOLA 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
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

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

res

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-042
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
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-IONONE (UNII: I9V075M61R)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)
CORALLINA OFFICINALIS (UNII: 4004498D06)
TURMERIC (UNII: 856YO1Z64F)
CARROT SEED OIL (UNII: 595AO13F11)
DECANAL (UNII: 31Z90Q7KQJ)
.DELTA.-DODECALACTONE (UNII: 33DIC582TL)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
DIMETHICONE (UNII: 92RU3N3Y1O)
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
ETHYL FERULATE (UNII: 5B8915UELW)
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SUNFLOWER OIL (UNII: 3W1JG795YI)
3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4)
HEXYL ACETATE (UNII: 7U7KU3MWT0)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)
HOLY BASIL LEAF (UNII: SCJ765569P)
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
RASPBERRY SEED OIL (UNII: 9S8867952A)
EGGPLANT (UNII: W5K7RAS4VK)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITYL LAURATE (UNII: 23XPH3M9LR)
TRIDECANE (UNII: A3LZF0L939)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
UNDECANE (UNII: JV0QT00NUE)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-042-01	118 mL in 1 TUBE; Type 0: Not a Combination Product	03/02/2020

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)