Label: TONE CONTROL MORNING CREAM SPF 15- octocrylene and octisalate cream cream

  • NDC Code(s): 54111-173-20, 54111-173-60
  • Packager: Bentley Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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  • ACTIVE INGREDIENT

    DRUG FACTS

    Active Ingredients

    Octocrylene 5%

    Octisalate 2%

  • PURPOSE

    Purpose .... Sunscreem

  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn.

  • WARNINGS

    Warnings •Skin Cancer/Skin Aging Alert: Spending too much time in the sun increases your risk of
    skin cancer and early skin aging. This product has been shown to only help prevent sunburn,
    not skin cancer or early skin aging. • 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 rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed get medical help or contact a Poison Control center right away.

  • DOSAGE & ADMINISTRATION

    Directions• Apply generously 15 minutes before sun exposure. • Use in the morning.
    • Reapply every 2 hours. • Use a water resistant sunscreen if swimming or sweating. • Rub
    cream gently into your face and neck, avoiding the eyes.

  • OTHER SAFETY INFORMATION

    Other information • Protect the product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive Ingredients  Aloe Barbadensis Leaf Juice, Water, Butyloctyl Salicylate, Cetear-
    yl Olivate, Sorbitan Olivate, Glyceryl Stearate, Potassium Azeloyl Diglycinate, Glycerin, Niacina-
    mide, Polyglyceryl-10 Laurate, Sodium Hyaluronate, Silica, Caffeine, Phenoxyethanol, Caprylyl
    Glycol, Dimethicone, Sodium Stearoyl Glutamate, Hydroxyethyl Acrylate/Sodium
    Acryloyldimethyl Taurate Copolymer, Ethyl Ferulate, Ethylhexylglycerin, Arnica Montana Flower
    Extract

  • Product Labeling

    Tone Control Morning Cream SPF 15
    SPF 15

    Distributed by Geologie
    2578 Broadway #A212
    New York, NY 10025

    20 ml .67 fl oz

    20 mL Label

    173-20 pkg

    173-20 Card

    60 mL Label

    173-60 Card

    173-60 PKG

    res

  • INGREDIENTS AND APPEARANCE
    TONE CONTROL MORNING CREAM SPF 15 
    octocrylene and octisalate cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POTASSIUM AZELOYL DIGLYCINATE (UNII: N02RVN6NYP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAFFEINE (UNII: 3G6A5W338E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-173-2020 mL in 1 TUBE; Type 0: Not a Combination Product07/18/2023
    2NDC:54111-173-6060 mL in 1 TUBE; Type 0: Not a Combination Product07/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/18/2023
    Labeler - Bentley Laboratories, LLC (068351753)
    Registrant - Geologie (081158549)
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