COOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN 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 70%+ ORGANIC MINERAL BODY SUNSCREEN SPF50

Active ingredients

Titanium Dioxide 3.5%, Zinc Oxide 7.25%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor

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

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Amyris Balsamifera Bark Oil, Blue-Green (Algae) Extract (ORGANIC), Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Cananga Odorata Flower Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Chlorphenesin, Citrus Paradisi (Grapefruit) Peel Oil, Cocos Nucifera (Coconut) Oil (ORGANIC), Ethylhexylglycerin, Glycerin (ORGANIC), Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Magnesium Sulfate, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Neopentyl Glycol Diheptanoate, Olive Oil Polyglyceryl-6 Esters, Opuntia Ficus-Indica Flower Extract, Pelargonium Graveolens Flower Oil, Polyglyceryl-6 Pentaoleate, Polymethyl Methacrylate, Rubus Idaeus (Raspberry) Seed Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Triethyl Citrate, VP/Hexadecene Copolymer., Water

Other information

Label

CA52372 tube

CA00792 carton

CA00792 tube

CA00889 carton

CA00889 tube

COOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE72.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
COCONUT OIL (UNII: Q9L0O73W7L)  
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
GRAPEFRUIT OIL (UNII: YR377U58W9)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
CANANGA OIL (UNII: 8YOY78GNNX)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
JOJOBA OIL (UNII: 724GKU717M)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
OPUNTIA TUNA FLOWERING TOP (UNII: R4AS8333O2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-040-01148 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2019
2NDC:79753-040-02100 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2019
3NDC:79753-040-72946 mL in 1 TUBE; Type 0: Not a Combination Product01/18/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02006/01/2019
Labeler - COOLA, LLC (956990290)

Revised: 6/2023
Document Id: fd8d8777-b375-001a-e053-6394a90ab66a
Set id: cb95c712-1680-4040-e053-2995a90af004
Version: 2
Effective Time: 20230607
 
COOLA, LLC