OTC Medication Information: COOLA Mineral Body SPF 30 Tropical Coconut

COOLA MINERAL BODY SPF 30 TROPICAL COCONUT- 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.

Zinc Oxide — 14.2%

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
  • 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 skin rash occurs.

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
  • Reapply: • After 80 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours
  • Sun Protection Measure: 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. to 2 p.m. • Wear long-sleeved shirts, pants, hats, and sun glasses.

Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), Cocos Nucifera (Coconut) Oil (ORGANIC), Butyloctyl Salicylate, Cetearyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Methyl Dihydroabietate, Sodium Stearoyl Glutamate, Coco-Glucoside, Acacia Senegal Gum (ORGANIC), Caesalpinia Spinosa Gum (ORGANIC), Sodium Hyaluronate, Glycerin, Laminaria Digitata Extract (ORGANIC), Butyrospermum Parkii (Shea) Butter (ORGANIC), Theobroma Cacao (Cocoa) Seed Butter (ORGANIC), Bisabolol (ORGANIC), Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Mauritia Flexuosa Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Persea Gratissima (Avocado) Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Opuntia Ficus-Indica Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Caprylhydroxamic Acid, Caprylyl Glycol, Sodium Gluconate, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Water, Citric Acid, Gamma-Nonalactone, Gamma-Octalactone, Caprylic/Capric Triglyceride, Trans-2-hexenal, Vanillin, Maltol, Dimethyl Heptenal

  • May stain fabrics
  • Protect this product from excessive heat and direct sun

Call 760-940-2125

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COOLA MINERAL BODY SPF 30 TROPICAL COCONUT
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-053
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 14.2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
CAPRYLYL GLYCOL
ACACIA
SHEA BUTTER
COCOA BUTTER
MEDIUM-CHAIN TRIGLYCERIDES
VANILLIN
OPUNTIA FICUS-INDICA FLOWER
CAPRYLHYDROXAMIC ACID
ARACHIDYL GLUCOSIDE
SODIUM STEAROYL GLUTAMATE
COCO GLUCOSIDE
BUTYLOCTYL SALICYLATE
.GAMMA.-OCTALACTONE
CAMELINA SATIVA SEED OIL
COCONUT OIL
CAESALPINIA SPINOSA RESIN
MEADOWFOAM SEED OIL
.GAMMA.-NONALACTONE
MALTOL
CETOSTEARYL ALCOHOL
LAMINARIA DIGITATA
LEVOMENOL
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)
SAFFLOWER OIL
MAURITIA FLEXUOSA FRUIT OIL
BRASSICA RAPA SUBSP. OLEIFERA OIL
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES
DOCOSANOL
WATER
CITRIC ACID MONOHYDRATE
ORANGE
METHYL DIHYDROABIETATE
HYALURONATE SODIUM
GLYCERIN
RASPBERRY SEED OIL
SODIUM GLUCONATE
ARACHIDYL ALCOHOL
2-HEXENAL, (2E)-
ROSEMARY
SUNFLOWER OIL
AVOCADO OIL
2,6-DIMETHYL-5-HEPTENAL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79753-053-01 1 TUBE in 1 CARTON contains a TUBE
1 148 mL in 1 TUBE This package is contained within the CARTON (79753-053-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final M020 11/01/2019
Labeler — COOLA, LLC (956990290)

Revised: 11/2022 COOLA, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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