COOLA BARE REPUBLIC MINERAL SPORT SPF50 LOTION NON-NANO

COOLA BARE REPUBLIC MINERAL SPORT SPF50 NON-NANO by

Drug Labeling and Warnings

COOLA BARE REPUBLIC MINERAL SPORT SPF50 NON-NANO 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 SPF50 NON-NANO- 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 NON-NANO

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

Allyl Heptoate, Aloe Barbadensis Leaf Juice, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylglycerin, Gamma Decalactone, Gamma Nonalactone, Gamma Octalactone, Gluconolacetone, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Heliotropine, Magnesium Sulfate, Maranta Arundinacea Root Powder, Neopentyl Glycol Diheptanoate, Phenethyl Alcohol, Raspberry Ketone, Rubus Idaeus (Raspberry) Seed Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Hydroxide, Sodium Phytate, Sorbitan Sesquioleate, Sorbitan Tristearate, Stearyl/Octyldodecyl Citrate Crosspolymer, Stearyl Alcohol, Tocopheryl, Triethyl Citrate, Vanillin, Vitis Vinifera (Grape) Seed Oil, VP/Hexadecene Copolymer, Water

Label

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-011
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)
CARROT SEED OIL (UNII: 595AO13F11)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
GRAPE SEED OIL (UNII: 930MLC8XGG)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHYTATE SODIUM (UNII: 88496G1ERL)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
GLYCERIN (UNII: PDC6A3C0OX)
ALLYL HEPTANOATE (UNII: AU4CYG9V68)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
PIPERONAL (UNII: KE109YAK00)
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
VANILLIN (UNII: CHI530446X)
WATER (UNII: 059QF0KO0R)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
RASPBERRY SEED OIL (UNII: 9S8867952A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-011-71	148 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2021	01/01/2021

Labeler - COOLA, LLC (956990290)

Revised: 2/2023

Document Id: f4d84c2a-7b56-3ce4-e053-2a95a90a263e

34390-5

Set id: bca539b8-08b1-0aae-e053-2a95a90a9d12

Version: 2

Effective Time: 20230216

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