Label: COOLA CLASSIC LIPLUX LIP BALM SPF 30 TINTED- avobenzone, octisalate, octocrylene stick

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 22, 2024

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  • ACTIVE INGREDIENT

    Avobenzone – 2.9%
    Octisalate – 4.9%
    Octocrylene – 7.6%

  • 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.
    • 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

    • Apply liberally 15 minutes before sun exposure & again after 80 minutes of swimming or sweating.
    • Apply at least every 2 hours.
    • Sun Protection Measures - To decrease your risk of cancer and early skin aging, 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. and wear long-sleeved shirts, pants, hats, and sunglasses.
  • INACTIVE INGREDIENT

    Cocos Nucifera (Coconut) Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Euphorbia Cerifera (Candelilla) Wax, Theobroma Grandiflorum Seed Butter (ORGANIC), Ricinus Communis (Castor) Seed Oil (ORGANIC), Tapioca Starch (ORGANIC), Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Butyloctyl Salicylate, Calcium Sodium Borosilicate, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Polyhydroxystearic Acid, Titanium Dioxide, Maltodextrin, Flavor, Bisabolol (ORGANIC), Ipomoea Batatas Tuber Extract, Acacia Senegal Gum, Stevia Rebaudiana Extract, Octyldodecyl Oleate, Iron Oxides, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Citric Acid, Rosa Canina Fruit Extract (ORGANIC), Raphanus Sativus (Radish) Root Extract, Persea Gratissima (Avocado) Oil (ORGANIC), Tetrahexyldecyl Ascorbate, Caprylic/Capric Triglyceride, Tocopherol (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil, Linoleic Acid, Phospholipids, Phytosterols, Aloe Barbadensis Leaf Extract

  • OTHER SAFETY INFORMATION

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

  • QUESTIONS

    Call 760-940-2125

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    COOLA CLASSIC LIPLUX LIP BALM SPF 30 TINTED 
    avobenzone, octisalate, octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559)  
    SOY STEROL (UNII: PL360EPO9J)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    ROSEMARY (UNII: IJ67X351P9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    SWEET POTATO (UNII: M9WGG9Z9GK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ACACIA (UNII: 5C5403N26O)  
    RADISH (UNII: EM5RP35463)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-019-011 in 1 CARTON07/01/2021
    14.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/01/2021
    Labeler - COOLA, LLC (956990290)
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