Label: ESIKA MAXIMUM COLOR LIPSTICK SPF 18- octinoxate and oxybenzone lipstick

  • 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 December 8, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate 7.3 %, Oxybenzone 1.65%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
  • Warnings

    • Skin Cancer / Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    • For external use only.

    • Do not use on damage 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 and evenly 15 minutes before sun exposure.
    • Children under 6 months of age: Ask a doctor.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients

    diisopropyl dimer dilinoleate, ethylhexyl palmitate, ozokerite, copernicia cerifera (carnauba) wax, polyethylene, butyrospermum parkii (shea) butter, silica, octyldodecanol, water, phenoxyethanol, microcrystalline wax, petrolatum, phospholipids, methylparaben, fragrance, bht, cholesterol, butylparaben, ethylparaben, euphorbia cerifera (candelilla) wax, beeswax, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, propylparaben, glycosphingolipids, maltodextrin, zea mays (corn) starch, sodium hyaluronate. May contain: red 7 lake, red 27 lake, iron oxides, mica, yellow 5 lake, titanium dioxide, red 6 lake, isononyl isononanoate, talc, isopropyl myristate, blue 1 lake, carmine, isopropyl titanium triisostearate, triethoxycaprylylsilane, stearalkonium hectorite, C9-15 fluoroalcohol phosphate, polyhydroxystearic acid, propylene carbonate.

  • SPL UNCLASSIFIED SECTION

    Dist. by Ventura Corporation, Ltd.
    San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 4 g Tube Carton

    ēsika

    Maximum Color
    Lipstick SPF 18

    4 g e (.14 oz.)

    Principal Display Panel - 4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ESIKA   MAXIMUM COLOR LIPSTICK SPF 18
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-442
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.073 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0165 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    diisopropyl dilinoleate (UNII: 5323S7S2LR)  
    ethylhexyl palmitate (UNII: 2865993309)  
    carnauba wax (UNII: R12CBM0EIZ)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    octyldodecanol (UNII: 461N1O614Y)  
    water (UNII: 059QF0KO0R)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    petrolatum (UNII: 4T6H12BN9U)  
    methylparaben (UNII: A2I8C7HI9T)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    starch, corn (UNII: O8232NY3SJ)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    mica (UNII: V8A1AW0880)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    isononyl isononanoate (UNII: S4V5BS6GCX)  
    talc (UNII: 7SEV7J4R1U)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    isopropyl titanium triisostearate (UNII: 949E3KBJ1I)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    propylene carbonate (UNII: 8D08K3S51E)  
    aluminum oxide (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-442-021 in 1 BOX
    1NDC:13537-442-014 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/06/2012
    Labeler - Ventura Corporation LTD. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-442)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yobel Supply Chain Management S.A. (Peru)934116930MANUFACTURE(13537-442)
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