Label: EXUVIANCE DAILY CORRECTOR WITH SUNSREEN BROAD SPECTRUM SPF 35- octinoxate, octisalate, and avobenzone cream

  • NDC Code(s): 58414-0024-1
  • Packager: NeoStrata Company Inc.
  • 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 September 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 3%
    Octinoxate 7.5%
    Octisalate 5%

  • Purpose

    Sunscreen

  • Uses

    • 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 a Poison Control Center right away.

  • Directions

    • Apply liberally to face and neck daily, 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Sun 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 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-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor
  • Inactive ingredients

    Water, Acetyl Glucosamine, Butyloctyl Salicylate, Dimethicone, C12-15 Alkyl Benzoate, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, Butylene Glycol, Cyclohexasiloxane, Octyldodecyl Neopentanoate, Cetyl Alcohol, PEG-100 Stearate, Cetearyl Alcohol, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Extract, Tetrahydrodiferuloylmethane, 4-Butylresorcinol, Ceteth-20, PEG-75 Stearate, Propylene Glycol, Disodium EDTA, Steareth-20, Xanthan Gum, Ammonium Hydroxide, Sodium Bisulfite, Carbomer, Caprylyl Glycol, Phenoxyethanol, Chlorphenesin,

  • Other information

    • Store at 15°C-30°C (59°F – 86°F)
    • Protect this product from excessive heat and direct sun
    • For easy product dispensing, store tube upright on its cap.
  • Questions or comments?

    Call toll-free 1-800-225-9411 (9am – 5pm ET)

  • PRINCIPAL DISPLAY PANEL - 40 g Tube Carton

    exuviance ®

    FOCUS

    oily
    acne prone
    DAILY CORRECTOR
    WITH SUNSCREEN
    BROAD SPECTRUM SPF 35
    Reduce the visible
    signs of aging
    Smooth, improve
    skin tone
    NeoGlucosamine
    B-Resorcinol
    Turmeric Extract
    Grape Seed Extract

    Net Wt 40 g/1.4 oz

    Principal Display Panel - 40 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    EXUVIANCE DAILY CORRECTOR   WITH SUNSREEN BROAD SPECTRUM SPF 35
    octinoxate, octisalate, and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58414-0024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    4-BUTYLRESORCINOL (UNII: 2IK4UQ3ZGA)  
    TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CETETH-20 (UNII: I835H2IHHX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BISULFITE (UNII: TZX5469Z6I)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    AMMONIA (UNII: 5138Q19F1X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58414-0024-11 in 1 CARTON10/01/2019
    140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35210/01/2019
    Labeler - NeoStrata Company Inc. (605754829)
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