Label: CLEARLY ZINQ MINERAL GEL SUNSCREEN BS SPF 60- zinc oxide gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient,

    Zinc Oxide – 24 %

  • PURPOSE

    Purpose; Sunscreen

  • INDICATIONS & USAGE

    Uses. Helps prevent sunburn.

    If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

    When using this product keep out of eye.Rinse with water to remove.

  • STOP USE

    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.

  • DOSAGE & ADMINISTRATION

    Directions.

    Apply generously and evenly 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 the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use of 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.

  • OTHER SAFETY INFORMATION

    Other information.

    Protect this product from excessive heat an direct sun.

    May stain some fabrics.

  • INACTIVE INGREDIENT

    Inactive ingredient:

    Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polymethylsilsesquioxane, C13-15Alkane, stearalkonium Hectorite,Propylene Carbonate, Quaternium-90 Bentonite, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera ( Carnauba) Wax, Bytyrospermum Parkii Nut Extract, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Carthamus Tinctorius ( Safflower) Seed Oil, Aloe Barbandensis Leaf Extract, Dimethicon, Triethyl Citrate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol.

  • PRINCIPAL DISPLAY PANEL

    Clearly Zinq Mineral Gel Sunscreen BS SPF 60

  • INGREDIENTS AND APPEARANCE
    CLEARLY ZINQ MINERAL GEL SUNSCREEN BS SPF 60 
    zinc oxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4236
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SHEANUT (UNII: 84H6HBP32L)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4236-196 g in 1 TUBE; Type 0: Not a Combination Product12/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/04/2023
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4236)