Label: COOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 79753-040-01, 79753-040-02, 79753-040-72
  • 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 June 7, 2023

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  • Active ingredients

    Titanium Dioxide 3.5%, Zinc Oxide 7.25%

  • 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

  • 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 the reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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 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 6 months of age: Ask a doctor
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice (ORGANIC), Amyris Balsamifera Bark Oil, Blue-Green (Algae) Extract (ORGANIC), Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Cananga Odorata Flower Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Chlorphenesin, Citrus Paradisi (Grapefruit) Peel Oil, Cocos Nucifera (Coconut) Oil (ORGANIC), Ethylhexylglycerin, Glycerin (ORGANIC), Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Magnesium Sulfate, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Neopentyl Glycol Diheptanoate, Olive Oil Polyglyceryl-6 Esters, Opuntia Ficus-Indica Flower Extract, Pelargonium Graveolens Flower Oil, Polyglyceryl-6 Pentaoleate, Polymethyl Methacrylate, Rubus Idaeus (Raspberry) Seed Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Triethyl Citrate, VP/Hexadecene Copolymer., Water

  • Other information

    • protect this product from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces
  • Label

    CA52372 tube

    CA00792 carton

    CA00792 tube

    CA00889 carton

    CA00889 tube

  • INGREDIENTS AND APPEARANCE
    COOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE72.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    CANANGA OIL (UNII: 8YOY78GNNX)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    JOJOBA OIL (UNII: 724GKU717M)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    OPUNTIA TUNA FLOWERING TOP (UNII: R4AS8333O2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-040-01148 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2019
    2NDC:79753-040-02100 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2019
    3NDC:79753-040-72946 mL in 1 TUBE; Type 0: Not a Combination Product01/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02006/01/2019
    Labeler - COOLA, LLC (956990290)
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