Label: COOLA CLASSIC BODY SPF 30 TROPICAL COCONUT- avobenzone, octisalate, octocrylene spray
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Contains inactivated NDC Code(s)
NDC Code(s): 79753-062-01 - Packager: COOLA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 10, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
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WARNINGS
- For external use only
- Flammable: Contents under pressure. Do not puncture or incinerat. Do not store at temperatures above 120 F. Do not use in the presence of a flame or spark, or while smoking.
- Do not use on damaged or broken skin.
- When using this product keep away from face to avoid breathing. Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as it could cause surface to become slippery. Do not apply in windy conditions. Use in a well-ventilated area.
- Stop use and ask a doctor if rash occurs.
- KEEP OUT OF REACH OF CHILDREN
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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.
- Reapply: After 80 minutes of swimming or sweating. Immediately after 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 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.
- Children under six months: Ask a doctor.
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INACTIVE INGREDIENT
Alcohol (ORGANIC), Butyloctyl Salicylate, Methyl Dihydroabietate, Aloe Barbadensis Leaf Juice, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Opuntia Ficus-Indica Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Citric Acid, Dimethyl Heptenal, Gamma-Nonalactone, Sodium Benzoate, Maltol, Potassium Sorbate, Trans-2-hexenal, Triethyl Citrate, Vanillin, 5-Butyldihydro-2(3H)-Furanone
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLA CLASSIC BODY SPF 30 TROPICAL COCONUT
avobenzone, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-062 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.8 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.6 g in 100 mL Inactive Ingredients Ingredient Name Strength MALTOL (UNII: 3A9RD92BS4) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) 2-HEXENAL, (2E)- (UNII: 69JX3AIR1I) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) VANILLIN (UNII: CHI530446X) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALCOHOL (UNII: 3K9958V90M) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SAFFLOWER OIL (UNII: 65UEH262IS) OPUNTIA FICUS-INDICA SEED OIL (UNII: 1XGW49AK2J) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) RASPBERRY SEED OIL (UNII: 9S8867952A) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-062-01 177 mL in 1 CAN; Type 0: Not a Combination Product 10/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/01/2019 Labeler - COOLA, LLC (956990290)
