EXUVIANCE PROFESSIONAL SHEER REFINING FLUID WITH SUNSCREEN BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LOTION [NEOSTRATA COMPANY INC.]

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  • EXUVIANCE PROFESSIONAL SHEER REFINING FLUID WITH SUNSCREEN BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LOTION [NEOSTRATA COMPANY INC.]

EXUVIANCE PROFESSIONAL SHEER REFINING FLUID WITH SUNSCREEN BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LOTION [NEOSTRATA COMPANY INC.]
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NDC 58414-0021-1, 58414-0021-2
Set ID 79055976-7859-4f1d-987a-e993664e4982
Category HUMAN OTC DRUG LABEL
Packager NeoStrata Company Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 3.0%
    Octinoxate 7.5%
    Octisalate 5.0%

  • 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

    Aqua/Water/Eau, Acetyl Glucosamine, Butyloctyl Salicylate, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Butylene Glycol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Cetyl Alcohol, PEG-100 Stearate, Cetearyl Alcohol, Tocopheryl Acetate, Melia Azadirachta Leaf Extract, Arctium Lappa Root Extract, Vitis Vinifera (Grape) Seed Extract, Lecithin, Dimethicone Crosspolymer, Propylene Glycol, PEG-75 Stearate, Xanthan Gum, Disodium EDTA, Ceteth-20, Steareth-20, Carbomer, Caprylyl Glycol, Ammonium Hydroxide, Phenoxyethanol, Chlorphenesin, Sodium Bisulfite.

  • Other information

    • Store at 15°C-30°C (59°F-86°F)
    • Protect this product from excessive heat and direct sun
  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    DAILY
    REGIMEN

    Exuviance®
    PROFESSIONAL

    SHEER
    REFINING FLUID
    WITH SUNSCREEN
    BROAD SPECTRUM SPF 40

    HYDRATES WITHOUT
    GREASINESS

    REDUCES APPEARANCE OF
    PORES, EVENS SKIN TONE

    NEOGLUCOSAMINE + AOX

    50 mL/1.7 fl oz

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    EXUVIANCE PROFESSIONAL SHEER REFINING FLUID   WITH SUNSCREEN BROAD SPECTRUM SPF 40
    octinoxate, octisalate, and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58414-0021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    AMMONIA (UNII: 5138Q19F1X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM BISULFITE (UNII: TZX5469Z6I)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58414-0021-11 in 1 CARTON11/01/201810/18/2021
    150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:58414-0021-21 in 1 CARTON11/01/201811/18/2021
    2227 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/01/201811/18/2021
    Labeler - NeoStrata Company Inc. (605754829)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Essence, LLC032565959MANUFACTURE(58414-0021)
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