COOLA SPF 30 MINERAL SUNSCREEN FRAGRANCE FREE- zinc oxide spray 
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 Mineral Spray SPF 30 - Unscented

Zinc Oxide - 14.5%

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.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Shake well. Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. • When properly used, mineral sunscreens will leave a whitish tint when first applied.

• Reapply: • after 80 minutes of swimming or sweating • immediately afrer towel drying • at least every 2 hours
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 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-sleeve shirts, pants, hats, and sunglasses

• Children under 6 months: Ask a doctor

Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), WaterSimmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil (ORGANIC), Methyl Dihydroabietate, Bentonite, Cetearyl Alcohol, Aloe Barbadensis Leaf Juice (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Opuntia Ficus-Indica Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Shea Butter Ethyl Esters, Propanediol, Glycerin (ORGANIC), Coco-Glucoside, Laminaria Digitata (Algae) Extract (ORGANIC), Microcrystalline Cellulose, Cellulose Gum, Sodium Stearoyl Glutamate, Caprylhydroxamic Acid, Caprylyl Glycol, Capryloyl Glycerin/Sebacic Acid Copolymer, Citric Acid

Call 760-940-2125

1

COOLA SPF 30 MINERAL SUNSCREEN FRAGRANCE FREE 
zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
BENTONITE (UNII: A3N5ZCN45C)  
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LEVOMENOL (UNII: 24WE03BX2T)  
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
PROPANEDIOL (UNII: 5965N8W85T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ROSEMARY (UNII: IJ67X351P9)  
ORANGE (UNII: 5EVU04N5QU)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
COCO GLUCOSIDE (UNII: ICS790225B)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
JOJOBA OIL (UNII: 724GKU717M)  
COCONUT OIL (UNII: Q9L0O73W7L)  
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-049-01148 mL in 1 CAN; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/01/2019
Labeler - COOLA, LLC (956990290)

Revised: 11/2022
Document Id: edc60967-2f80-42d4-e053-2a95a90abec8
Set id: edc6048e-0ea0-41c5-e053-2a95a90a96d9
Version: 1
Effective Time: 20221118
 
COOLA, LLC