Label: POWERPATCH DARK SPOT PROTECTOR- avobenzone, homosalate, octisalate, octocrylene, oxbenzone gel

  • 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 July 22, 2016

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

  • DARK SPOT PROTECTIOR SUNSCREEN GELBROAD SPECTRUM SPF 30:Drug FactsActive ingredient(s)

    Avobenzone 3%

    Homosalate 8%

    Octisalate 5%

    Octocrylene 2.8%

    Oxybenzone 3%

  • Purpose

    Sunscreen

  • Keep out of reach of children

    Keep out of reach of children.

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

  • Uses

    • helps prevent sunburn
  • Warnings

    For external use only

  • Do not use

    on damaged or broken skin

  • When using this product

    keep out of the eyes. Rinse with water to remove.

  • Stop use and ask a doctor

    if rash occurs

  • Directions

    For sunscreen use

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months ask a doctor

    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
  • Inactive ingredients

    Alcohol, Algae Extract, BHT, Butylene Glycol, Butyloctyl Salicylate, Hydrogenated Glyceryl Abietate, Isododecane & Dimethicone/Bis-isobutyl PPG-copolymer, Isoarryl Cocoate, Isoamyl Laurate, Kiwi fruit Water, Lemon Oil, Licorice Root Extract, Menthone Glycerin Acetyl, Pomegranate Oil, Sophora Flavescens Root Extract, Tumeric Extract

  • Other information

    Protect this product from excessive heat and direct sun

  • Questions or comments?

    Call toll free 1-888-243-0646

  • Dark Spot Corrector product label

    patchology®

    POWERPATCH™

    DARK SPOT PROTECTOR
    SUNSCREEN GEL
    BROAD SPECTRUM SPF 30

    20 mL

    DARK SPOT PROTECTOR SUNSCREEN GEL

    BROAD SPECTRUM SPF 30

    Shades spots from skin-damaging rays during the day.

    For use withPowerPatch Dark Spot Corrector Patches.

    DIRECTIONS

    Apply a thin layer of gel over treatment area only. Use every morning after cleansing.

    IF IRRITATION OCCURS, STOP USE AND RINSE THOROUGHLY WITH WATER.

    DIST. BY/PAR IONTERA, INC.,

    DEDHAM, MA 02026
    ALL RIGHTS RESERVED
    MADE IN THE USA

    QUESTIONS?
    1-888-243-0646
    PATCHOLOGY.COM

    RR PPP Dark Spot

    RR PPP Dark Spot 2

  • INGREDIENTS AND APPEARANCE
    POWERPATCH DARK SPOT PROTECTOR 
    avobenzone, homosalate, octisalate, octocrylene, oxbenzone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0588
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.6 g  in 20 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE1.6 g  in 20 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.0 g  in 20 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.56 g  in 20 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.6 g  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    LAMINARIA ANGUSTATA (UNII: 2J2UIK8XBZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL ABIETATE (UNII: 2F22LY70Q1)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    ISOAMYL COCOATE (UNII: 14OG46E98E)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    LEMON OIL (UNII: I9GRO824LL)  
    LICORICE (UNII: 61ZBX54883)  
    MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    TURMERIC (UNII: 856YO1Z64F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0588-120 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/01/2016
    Labeler - Raining Rose (083819404)
    Registrant - Raining Rose (083819404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose083819404manufacture(65692-0588)