Label: COOLA SPF 30 MINERAL SUNSCREEN FRAGRANCE FREE- zinc oxide spray

  • 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

    Zinc Oxide - 14.5%

  • PURPOSE

    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.

  • 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

    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

  • OTHER SAFETY INFORMATION

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

    Call 760-940-2125

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    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)