Label: REACTIVE PLUS ANTI-OXIDANT SERUM PLUS BROAD-SPECTRUM SPF 45- octinoxate and zinc oxide lotion

  • NDC Code(s): 46783-222-04, 46783-222-30
  • Packager: Merz North America, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 7, 2022

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  • Drug Facts

  • Active Ingredients

    Octinoxate 5.0%
    Zinc Oxide 5.1%

  • 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 generously 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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 value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10am - 2pm
      • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: ask a doctor
  • Inactive Ingredients

    Cyclopentasiloxane, Ascorbic Acid, Ethylhexyl Hydroxystearate, Polysilicone-11, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Polyester-7, Tocopherol, Creatine, Epigallocatechin Gallate, Triethoxycaprylylsilane, Neopentyl Glycol Diheptanoate, Disteardimonium Hectorite, Polyhydroxystearic Acid, Propylene Carbonate, Dimethylmethoxy Chromanol, BHT

  • Other Information

    • protect the product in this container from excessive heat and direct sun
  • Questions?

    1.844.469.6379

  • PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton

    reactive+

    ANTI-OXIDANT SERUM +
    BROAD-SPECTRUM SPF 45

    NEOCUTIS®

    Principal Display Panel - 30 ML Bottle Carton
  • INGREDIENTS AND APPEARANCE
    REACTIVE PLUS ANTI-OXIDANT SERUM PLUS BROAD-SPECTRUM SPF 45 
    octinoxate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46783-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE51 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    POLYESTER-7 (UNII: 0841698D2F)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CREATINE (UNII: MU72812GK0)  
    EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46783-222-301 in 1 CARTON06/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:46783-222-044 mL in 1 TUBE; Type 0: Not a Combination Product06/15/201904/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/01/2018
    Labeler - Merz North America, Inc (028147846)
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