Label: SKIN WHITE PRO STRENGTH KOJIC AND HYALURONIC SKIN LIGHTENING SERUM solution

  • NDC Code(s): 84785-0010-1, 84785-0010-2
  • Packager: Gazebo Wellness SKIN LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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  • DOSAGE & ADMINISTRATION

    Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

  • WARNINGS

    Directions: Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Organic Coconut Oil, Grapeseed Oil, Emulsifying Wax, Stearic Acid, Glycerin, Xanthan Gum, Propylene Glycol, Undecylenoyl Phenylalanine, Phenoxyethanol, Tetrasodium Glutamate Diacetate.

  • ACTIVE INGREDIENT

    Active ingredients: Magnesium Ascorbyl Phosphate, Niacinamide B3, Glycolic Acid, Lactic Acid, Hyaluronic Acid, Kojic Acid, Alpha Arbutin, Hydrolyzed Oat Protein, Ethyl Ascorbic Acid, DL-Alpha Tocopherol (Vitamin E).

  • INDICATIONS & USAGE

    Directions: Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Pro Strength Treatment
    Skin White
    Fade & Remove Dark Spots, Melasma, Acne Scars, & More
    Formulated with Kojic Acid, Alpha Arbutin, Lactic Acid, Glycolic Acid, Ferulic Acid, Vitamin B3 + C + E

    Distributed By: Skin Beauty Solutions Elk Grove CA 95759
    MADE NUSA

  • PRINCIPAL DISPLAY PANEL

    Content of labeling

    Content of labeling 2oz 60 mlContent of labeling 4oz 60 ml

  • INGREDIENTS AND APPEARANCE
    SKIN WHITE PRO STRENGTH KOJIC AND HYALURONIC SKIN LIGHTENING SERUM 
    skin white pro strength kojic and hyaluronic skin lightening serum solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84785-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID0.3 mg  in 30 mL
    GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID0.3 mg  in 30 mL
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID0.3 mg  in 30 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.3 mg  in 30 mL
    KOJIC ACID (UNII: 6K23F1TT52) (KOJIC ACID - UNII:6K23F1TT52) KOJIC ACID0.3 mg  in 30 mL
    ALPHA-ARBUTIN (UNII: 72VUP07IT5) (ALPHA-ARBUTIN - UNII:72VUP07IT5) ALPHA-ARBUTIN0.3 mg  in 30 mL
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID0.3 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) 0.3 mg  in 30 mL
    COCONUT OIL (UNII: Q9L0O73W7L)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 0.3 mg  in 30 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84785-0010-160 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2024
    2NDC:84785-0010-260 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/01/2024
    Labeler - Gazebo Wellness SKIN LLC (119609953)
    Registrant - Gazebo Wellness SKIN LLC (119609953)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gazebo Wellness SKIN LLC119609953manufacture(84785-0010)
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