Label: ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (BEIGE 1) - BEIGE- titanium dioxide stick
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (BEIGE 2) - BEIGE- titanium dioxide stick
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (BEIGE 3) - BEIGE- titanium dioxide stick
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (BEIGE 4) - BEIGE- titanium dioxide stick
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (BEIGE 5) - BEIGE- titanium dioxide stick
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (BEIGE 6) - BEIGE- titanium dioxide stick
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (ROSA 1) - PINK- titanium dioxide stick
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (ROSA 2) - PINK- titanium dioxide stick
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (ROSA 3) - PINK- titanium dioxide stick
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (ROSA 4) - PINK- titanium dioxide stick
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (ROSA 5) - PINK- titanium dioxide stick
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (ROSA 6) - PINK- titanium dioxide stick

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    13537-209-01, 13537-209-02, 13537-210-03, 13537-210-04, view more
    13537-211-05, 13537-211-06, 13537-212-07, 13537-212-08, 13537-213-09, 13537-213-10, 13537-214-11, 13537-214-12, 13537-215-13, 13537-215-14, 13537-216-15, 13537-216-16, 13537-217-17, 13537-217-18, 13537-218-19, 13537-218-20, 13537-219-21, 13537-219-22, 13537-221-23, 13537-221-24
  • Packager: Ventura Corporation LTD
  • Category: HUMAN OTC DRUG LABEL

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 8, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Titanium dioxide 4%

  • 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. Rinse with water to remove. If swallowed, get medical help or contact a Poison Control Center right away.

    • For external use only.

    • Do not use on damaged or broken skin.

    • When using this product keep out of eyes.

    • 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.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor
  • Other information

    • Protect this product in this container form excesive heat and direct sun.
  • Inactive ingredients

    Ethylhexyl palmitate, c12-15 alkyl benzoate, caprylic/capric triglyceride, mica, di-ppg-3 myristyl ether adipate, sorbitan isostearate, ozokerite, polyethylene, copernicia cerifera cera (carnauba) wax, polymethyl methacrylate, zea mays (corn) starch , beeswax, helianthus annuus seed oil (sunflower) seed oil, phenoxyethanol, calendula officinalis flower extract, methylparaben, dimethicone, fragrance, peg-40 hydrogenated castor oil, polysorbate 80, ppg-26-buteth-26, butylparaben, c9-13 fluoroalcohol, ethylparaben, hedera helix (ivy) leaf/stem extract, trimethylsiloxysilicate, retinyl palmitate, phosphoric acid, tocopheryl acetate, isobutylparaben, propylparaben, bioflavonoids, allantoin, ascorbyl palmitate. May contain: titanium dioxide, iron oxides, chitosan.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 1

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - BEIGE 1
  • PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 2

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - BEIGE 2
  • PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 3

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - BEIGE 3
  • PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 4

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - BEIGE 4
  • PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 5

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - BEIGE 5
  • PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 6

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - BEIGE 6
  • PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 1

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - ROSA 1
  • PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 2

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - ROSA 2
  • PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 3

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - ROSA 3
  • PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 4

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - ROSA 4
  • PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 5

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - ROSA 5
  • PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 6

    ēsika

    PERFECT SKIN COVERAGE CONCEALER SPF 17

    Net Weight 0.07 oz. (2 g)

    Principal Display Panel - 2 g Carton - ROSA 6
  • INGREDIENTS AND APPEARANCE
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 1) - BEIGE
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-209
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-209-021 in 1 BOX
    1NDC:13537-209-012 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 2) - BEIGE
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-210-041 in 1 BOX
    1NDC:13537-210-032 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 3) - BEIGE
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-211-061 in 1 BOX
    1NDC:13537-211-052 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 4) - BEIGE
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-212-081 in 1 BOX
    1NDC:13537-212-072 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 5) - BEIGE
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-213-101 in 1 BOX
    1NDC:13537-213-092 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 6) - BEIGE
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-214-121 in 1 BOX
    1NDC:13537-214-112 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 1) - PINK
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-215-141 in 1 BOX
    1NDC:13537-215-132 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 2) - PINK
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-216-161 in 1 BOX
    1NDC:13537-216-152 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 3) - PINK
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-217
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-217-181 in 1 BOX
    1NDC:13537-217-172 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 4) - PINK
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-218
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-218-201 in 1 BOX
    1NDC:13537-218-192 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 5) - PINK
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-219-221 in 1 BOX
    1NDC:13537-219-212 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 6) - PINK
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ethylhexyl palmitate (UNII: 2865993309)  
    alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    mica (UNII: V8A1AW0880)  
    di-ppg-3 myristyl ether adipate (UNII: T32481VTXW)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    sunflower oil (UNII: 3W1JG795YI)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    methylparaben (UNII: A2I8C7HI9T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    phosphoric acid (UNII: E4GA8884NN)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    propylparaben (UNII: Z8IX2SC1OH)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-221-241 in 1 BOX
    1NDC:13537-221-232 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-209, 13537-210, 13537-211, 13537-212, 13537-213, 13537-214, 13537-215, 13537-216, 13537-217, 13537-218, 13537-219, 13537-221)