Label: NEOSTRATA ENLIGHTEN SKIN BRIGHTENER WITH SUNSCREEN BROAD SPECTRUM SPF 35- octinoxate, octisalate, and avobenzone cream

  • NDC Code(s): 58414-0019-1
  • 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 August 31, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (w/w)

    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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply sunscreen 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-Butyl-resorcinol, 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
  • Questions?

    1-800-628-9904

  • PRINCIPAL DISPLAY PANEL - 40 g Tube Carton

    NEOSTRATA ®
    ENLIGHTEN
    UNEVEN TONE AND
    DARK SPOTS
    Skin Brightener
    with Sunscreen Broad
    Spectrum SPF 35
    NET WT
    40 g / 1.4 OZ

    PRINCIPAL DISPLAY PANEL - 40 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    NEOSTRATA ENLIGHTEN SKIN BRIGHTENER   WITH SUNSCREEN BROAD SPECTRUM SPF 35
    octinoxate, octisalate, and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58414-0019
    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)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    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)  
    AMMONIA (UNII: 5138Q19F1X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58414-0019-11 in 1 CARTON12/01/2018
    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 FINALpart35212/01/2018
    Labeler - NeoStrata Company Inc. (605754829)
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