Label: COOLA SPF 30 MINERAL SUNSCREEN FRAGRANCE FREE- zinc oxide spray
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Contains inactivated NDC Code(s)
NDC Code(s): 79753-049-01 - 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 18, 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 incinerate. 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 in • Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as could cause surface to become slippery. Do not apply in windy conditions. Use in a well ventilated area.
- Stop use and ask doctor if skin 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. • 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
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLA SPF 30 MINERAL SUNSCREEN FRAGRANCE FREE
zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-049 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-049-01 148 mL in 1 CAN; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/01/2019 Labeler - COOLA, LLC (956990290)