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 
Ventura Corporation LTD

----------

PERFECT SKIN COVERAGE CONCEALER SPF 17

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, notskin 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 useon damaged or broken skin.

  • When using this productkeep out of eyes.

  • Stop use and ask a doctor ifrash 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.

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
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 BOX12/16/201312/31/2021
1NDC:13537-209-012 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:13537-210-032 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:13537-211-052 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:13537-212-072 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:13537-213-092 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:13537-214-112 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:13537-215-132 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:13537-216-152 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:13537-217-172 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:13537-218-192 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:13537-219-212 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:13537-221-232 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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)

Revised: 4/2025
Document Id: 334e32a4-c3a9-e37d-e063-6294a90ad6cf
Set id: d59348d1-8c8b-403b-bc10-4e5fade9ca79
Version: 3
Effective Time: 20250421
 
Ventura Corporation LTD