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

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 by

Drug Labeling and Warnings

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 2

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

Net Weight 0.07 oz. (2 g)

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 4

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

Net Weight 0.07 oz. (2 g)

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 6

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

Net Weight 0.07 oz. (2 g)

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 2

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

Net Weight 0.07 oz. (2 g)

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 4

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

Net Weight 0.07 oz. (2 g)

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 6

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

Net Weight 0.07 oz. (2 g)

INGREDIENTS AND APPEARANCE

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 1) - BEIGE
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-209
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-209-02	1 in 1 BOX
1	NDC: 13537-209-01	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 2) - BEIGE
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-210-04	1 in 1 BOX
1	NDC: 13537-210-03	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 3) - BEIGE
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-211-06	1 in 1 BOX
1	NDC: 13537-211-05	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 4) - BEIGE
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-212-08	1 in 1 BOX
1	NDC: 13537-212-07	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 5) - BEIGE
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-213-10	1 in 1 BOX
1	NDC: 13537-213-09	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (BEIGE 6) - BEIGE
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-214-12	1 in 1 BOX
1	NDC: 13537-214-11	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 1) - PINK
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-215
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-215-14	1 in 1 BOX
1	NDC: 13537-215-13	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 2) - PINK
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-216-16	1 in 1 BOX
1	NDC: 13537-216-15	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 3) - PINK
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-217-18	1 in 1 BOX
1	NDC: 13537-217-17	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 4) - PINK
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-218
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-218-20	1 in 1 BOX
1	NDC: 13537-218-19	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 5) - PINK
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-219-22	1 in 1 BOX
1	NDC: 13537-219-21	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17   (ROSA 6) - PINK
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-221
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-221-24	1 in 1 BOX
1	NDC: 13537-221-23	2 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-209, 13537-210, 13537-211, 13537-212, 13537-213, 13537-214, 13537-215, 13537-216, 13537-217, 13537-218, 13537-219, 13537-221)