Label: COOLA MINERAL BODY SPF 30 TROPICAL COCONUT- zinc oxide lotion
- NDC Code(s): 79753-053-01, 79753-053-02
- 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 May 5, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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.
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INACTIVE INGREDIENT
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
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLA MINERAL BODY SPF 30 TROPICAL COCONUT
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-053 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.2 g in 100 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) ACACIA (UNII: 5C5403N26O) SHEA BUTTER (UNII: K49155WL9Y) COCOA BUTTER (UNII: 512OYT1CRR) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) VANILLIN (UNII: CHI530446X) OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) COCO GLUCOSIDE (UNII: ICS790225B) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) CAMELINA SATIVA SEED OIL (UNII: 12824X01L0) COCONUT OIL (UNII: Q9L0O73W7L) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) MALTOL (UNII: 3A9RD92BS4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAMINARIA DIGITATA (UNII: 15E7C67EE8) LEVOMENOL (UNII: 24WE03BX2T) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) SAFFLOWER OIL (UNII: 65UEH262IS) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) DOCOSANOL (UNII: 9G1OE216XY) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ORANGE (UNII: 5EVU04N5QU) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCERIN (UNII: PDC6A3C0OX) RASPBERRY SEED OIL (UNII: 9S8867952A) SODIUM GLUCONATE (UNII: R6Q3791S76) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) 2-HEXENAL, (2E)- (UNII: 69JX3AIR1I) ROSEMARY (UNII: IJ67X351P9) SUNFLOWER OIL (UNII: 3W1JG795YI) AVOCADO OIL (UNII: 6VNO72PFC1) 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-053-01 1 in 1 CARTON 11/01/2019 1 148 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:79753-053-02 1 in 1 CARTON 11/01/2019 2 100 mL in 1 TUBE; Type 0: Not a Combination Product 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)
