Label: COOLA MINERAL LIPLUX LIP BALM SPF 30 SKINNY DIP- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 2, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Titanium Dioxide 3.6%

    Zinc Oxide 3.0%

  • 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

    Acacia Decurrens Flower Wax, Butyrospermum Parkii (ORGANIC Shea Butter), C18-38 Alkyl Hydroxystearoyl Stearate, Caesalpinia
    Sappan Bark Extract, Cocos Nucifera (ORGANIC Coconut) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax, Flavor, Helianthus
    Annuus (ORGANIC Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Iron Oxides, Hydrogenated Castor Oil, Jojoba
    Esters, Mica, Octyldodecyl Oleate, Octyldodecyl PCA, Olea Europaea (ORGANIC Olive) Fruit Oil, Persea Gratissima (ORGANIC
    Avocado) Oil, Polyglycerin-3, Polyhydroxystearic Acid, Rosmarinus Officinalis (ORGANIC Rosemary) Leaf Extract, Schinziophyton
    Rautanenii Kernel Oil (ORGANIC), Silica, Stevia Rebaudiana Extract, Theobroma Cacao (ORGANIC Cocoa) Seed Butter, Theobroma
    Grandiflorum Seed Butter (ORGANIC), Tin Oxide

  • OTHER SAFETY INFORMATION

    Protect this product from excessive heat and direct sun.

  • QUESTIONS

    Call 760-940-2125

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    COOLA MINERAL LIPLUX LIP BALM SPF 30 SKINNY DIP 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.6 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    OCTYLDODECYL PCA (UNII: E25TY46YTD)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICA (UNII: V8A1AW0880)  
    ROSEMARY (UNII: IJ67X351P9)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)  
    STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
    CAESALPINIA SAPPAN BARK (UNII: R6995U1QSX)  
    FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79753-056-011 in 1 CARTON02/01/2019
    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 DrugM02002/01/2019
    Labeler - COOLA, LLC (956990290)