COOLA BARE REPUBLIC MINERAL SPORT SPF50- titanium dioxide, zinc oxide lotion

COOLA BARE REPUBLIC MINERAL SPORT SPF50 by

Drug Labeling and Warnings

COOLA BARE REPUBLIC MINERAL SPORT SPF50 by is a Otc medication manufactured, distributed, or labeled by COOLA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 2.9%, Zinc Oxide 7.8

Purpose

Sunscreen

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

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 a doctor if

• rash occurs.

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

• children under 6 months of age: ask a doctor
• 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 value 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-sleeved shirts, pants, hats, and sunglasses

Other information

• protect this product from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

Alcohol, AleuritesMoluccana (Kukui) Seed Oil, Algae Exract, Allyl Heptoate, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Gamma Decalactone, Gamma Nonalactone, Gamma Octalactone, Glycerin, Heliotropine, Isohecxadecane, Lauryl PEG-8 Dimethicone, Octyldodecyl Citrate Crosspolymer, PEG-8, Phenylpropenol, Raspberry Ketone, Silica, Sodium Chloride, Sodium Citrate, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethyl Citrate, Vanillin, Vegan Beeswax, Water

Label

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INGREDIENTS AND APPEARANCE

COOLA BARE REPUBLIC MINERAL SPORT SPF50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	78 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	29 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
KUKUI NUT OIL (UNII: TP11QR7B8R)
ALLYL HEPTANOATE (UNII: AU4CYG9V68)
ISOHEXADECANE (UNII: 918X1OUF1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
COCONUT OIL (UNII: Q9L0O73W7L)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
PIPERONAL (UNII: KE109YAK00)
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)
3-PHENYL-1-PROPANOL (UNII: U04IC2765C)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VANILLIN (UNII: CHI530446X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-029-71	148 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018
2	NDC: 79753-029-72	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/01/2018

Labeler - COOLA, LLC (956990290)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(79753-029)