COOLA BARE REPUBLIC MINERAL FACE-LOTION SPF 70- titanium dioxide 3.5% zinc oxide 15.8% lotion

Coola Bare Republic Mineral Face-Lotion by

Drug Labeling and Warnings

Coola Bare Republic Mineral Face-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

Titanium Dioxide 3.5%

Zinc Oxide 15.8%

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 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

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

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.

res

INGREDIENTS AND APPEARANCE

COOLA BARE REPUBLIC MINERAL FACE-LOTION  SPF 70
titanium dioxide 3.5% zinc oxide 15.8% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15.8 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALLYL HEPTANOATE (UNII: AU4CYG9V68)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
COCO GLUCOSIDE (UNII: ICS790225B)
CARROT (UNII: L56Z1JK48B)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
GLYCERIN (UNII: PDC6A3C0OX)
PIPERONAL (UNII: KE109YAK00)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ISOSTEARIC ACID (UNII: X33R8U0062)
LAURYL LAURATE (UNII: GPW77G0937)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DISODIUM PHTHALATE (UNII: QB14YV193C)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
VANILLIN (UNII: CHI530446X)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-041-01	59 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2020

Labeler - COOLA LLC (956990290)