COOLA BARE REPUBLIC MINERAL SPORT SPF30 LOTION

COOLA BARE REPUBLIC MINERAL SPORT SPF30 by

Drug Labeling and Warnings

COOLA BARE REPUBLIC MINERAL SPORT SPF30 by is a Otc medication manufactured, distributed, or labeled by COOLA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COOLA BARE REPUBLIC MINERAL SPORT SPF30- titanium dioxide, zinc oxide lotion 
COOLA, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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COOLA BARE REPUBLIC MINERAL SPORT SPF30 LOTION

Active ingredients

Titanium Dioxide 2.6%, Zinc Oxide 3.9%

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

COOLA BARE REPUBLIC MINERAL SPORT SPF30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	39 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
KUKUI NUT OIL (UNII: TP11QR7B8R)
ALLYL HEPTANOATE (UNII: AU4CYG9V68)
ISOHEXADECANE (UNII: 918X1OUF1E)
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WHITE WAX (UNII: 7G1J5DA97F)
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)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
VANILLIN (UNII: CHI530446X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-028-71	148 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018
2	NDC: 79753-028-72	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 not final	part352	11/01/2018	12/16/2022

Labeler - COOLA, LLC (956990290)

Revised: 2/2023

Document Id: f4d733c0-97c4-1966-e053-2995a90a5df4

34390-5

Set id: bc2f6431-541b-3469-e053-2995a90a4914

Version: 3

Effective Time: 20230216

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