COOLA BARE REPUBLIC MINERAL SPORT SPF50- 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 SPF50 LOTION

Active ingredients

Titanium Dioxide 2.9%, Zinc Oxide 7.8

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of the reach of children

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

Directions

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

-limit time in the sun, especially from 10 a.m.-2 p.m.

-wear long-sleeved shirts, pants, hats, and sunglasses

Other information

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

CA00704

CA00783

COOLA BARE REPUBLIC MINERAL SPORT SPF50 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE78 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE29 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
VANILLIN (UNII: CHI530446X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-029-71148 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
2NDC:79753-029-72946 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2018
Labeler - COOLA, LLC (956990290)

Revised: 2/2021
Document Id: bbf15e58-c161-d599-e053-2a95a90a0696
Set id: bbf15e58-c160-d599-e053-2a95a90a0696
Version: 1
Effective Time: 20210222
 
COOLA, LLC