Label: BENEFIT TRIPLE PERFORMING FACIAL BROAD SPECTRUM SPF15- avobenzone, octinoxate, octocrylene, sulisobenzone cream

  • NDC Code(s): 66472-043-01
  • Packager: Benefit Cosmetics, LLC
  • 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 February 1, 2019

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

  • Drug Facts

  • Active ingredients

    Avobenzone 3.00%
    Octinoxate 7.49%
    Octocrylene 2.00%
    Sulisobenzone 1.50%

    Purpose

    Sunscreen

  • Use

    • 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. Rinse with water to remove.

    Stop use and ask a doctor

    if rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: ask a doctor.
    • Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk,  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. till 2 p.m.

         • Wear long-sleeved shirts, pants, hats & sun glasses.

  • Other information

    Protect the product in this container from excessive heat or direct sun.

  • Inactive ingredients

    Aqua (Water), Glycerin, Dicaprylyl Carbonate, Butylene Glycol, Pentylene Glycol, Diglycerin, C14-22 Alcohols, Polymethyl Methacrylate, Silica, Betaine, Steareth-21, Phenoxyethanol, Phenyl Trimethicone, Coco-Glucoside, Parfum (Fragrance), C12-20 Alkyl Glucoside, Coconut Alcohol, Polyacrylamide, C13-14 Isoparaffin, Sodium Hydroxide, Decyloxazolidinone, Tetrasodium EDTA, Tocopheryl Acetate, Carbomer, Xanthan Gum, Laureth-7, Xylitylglucoside, Linalool, Anhydroxylitol, BHT, Xylitol, Hexyl Cinnamal, Limonene, Hyaluronic Acid, Sodium Hyaluronate, Tocopherol.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    BENEFIT TRIPLE PERFORMING FACIAL BROAD SPECTRUM SPF15 
    avobenzone, octinoxate, octocrylene, sulisobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66472-043
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74.9 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
    SULISOBENZONE (UNII: 1W6L629B4K) (SULISOBENZONE - UNII:1W6L629B4K) SULISOBENZONE15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIGLYCERIN (UNII: 3YC120743U)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BETAINE (UNII: 3SCV180C9W)  
    STEARETH-21 (UNII: 53J3F32P58)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DECYLOXAZOLIDINONE (UNII: 95K9FHM51V)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LAURETH-7 (UNII: Z95S6G8201)  
    XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    XYLITOL (UNII: VCQ006KQ1E)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66472-043-011 in 1 BOTTLE02/01/2019
    150.3 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/22/2015
    Labeler - Benefit Cosmetics, LLC (070826813)