Label: FRESH SUGAR LIP TREATMENT SPF 15- octinoxate and oxybenzone lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 31, 2010

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

  • ACTIVE INGREDIENT

    Active Ingredients: Octinoxate 7.49%

                                Oxybenzone 2%

  • WARNINGS

    Warnings: Avoid contact with the eyes. For external use only.

                    Keep out of reach of children. Discontinue use if signs

                    of irritation or rash appear. Contains Oxybenzone.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Fresh

    SUGAR

    LIP TREATMENT SPF 15


    4.3g       0.15oz


    Fresh Inc Boston 02118 USA


    image of carton

  • INGREDIENTS AND APPEARANCE
    FRESH SUGAR LIP TREATMENT SPF 15 
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49817-1990
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.49 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    White Wax (UNII: 7G1J5DA97F)  
    Castor Oil (UNII: D5340Y2I9G)  
    Jojoba Oil (UNII: 724GKU717M)  
    1-Decanol (UNII: 89V4LX791F)  
    Grape Seed Oil (UNII: 930MLC8XGG)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Wheat Germ Oil (UNII: 14C97E680P)  
    Avocado Oil (UNII: 6VNO72PFC1)  
    Meadowfoam Seed Oil (UNII: 412ZHA4T4Y)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    Ribes Nigrum Seed Oil (UNII: GKE1188837)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Apricot Seed Oil (UNII: 54JB35T06A)  
    Isostearic Acid (UNII: X33R8U0062)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49817-1990-41 in 1 CARTON
    1NDC:49817-1990-84.3 g in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2003
    Labeler - Guerlain (395158322)