ESIKA- titanium dioxide stick

ESIKA by

Drug Labeling and Warnings

ESIKA by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation (San Juan, P.R), Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium dioxide 4%

Use

Helps prevent sunburn.

Warnings

For external use only.

Stop use if skin rash occurs.

Keep out of reach of children.

Directions

Apply evenly before sun exposure and as needed. Apply lightly on the area you wish to cover.

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 (copernicia cerifera (carnauba) wax), polymethyl methacrylate, zea mays (corn) starch, cera alba (beeswax), calendula officinalis flower oil, phenoxyethanol, chitosan, methylparaben, dimethicone, parfum (fragrance), peg-40 hydrogenated castor oil, polysorbate 80, ppg-26-buteth-26, butylparaben, C9-13 fluoroalcohol, ethylparaben, hedera helix extract (hedera helix (ivy) leaf/stem extract), trimethylsiloxysilicate, phosphoric acid, isobutylparaben, propylparaben, tocopheryl acetate, retinyl palmitate, ascorbyl palmitate, bioflavonoids, allantoin, CI 77891 (titanium dioxide), CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides).

SPL UNCLASSIFIED SECTION

Dist. by Ventura International Ltd. San Francisco, CA 94111.

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 1

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 2

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 3

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 4

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 5

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 6

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 1

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 2

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 3

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 4

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 5

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 6

ēsika

PERFECT SKIN COVERAGE CONCEALER SPF 17

2 g e (.07 oz.)

INGREDIENTS AND APPEARANCE

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-037
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (BEIGE 1)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-037-02	1 in 1 BOX
1	NDC: 13537-037-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-038
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (BEIGE 2)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-038-02	1 in 1 BOX
1	NDC: 13537-038-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-039
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (BEIGE 3)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-039-02	1 in 1 BOX
1	NDC: 13537-039-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-040
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (BEIGE 4)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-040-02	1 in 1 BOX
1	NDC: 13537-040-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-041
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (BEIGE 5)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-041-02	1 in 1 BOX
1	NDC: 13537-041-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-042
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (BEIGE 6)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-042-02	1 in 1 BOX
1	NDC: 13537-042-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-043
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (ROSA 1)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-043-02	1 in 1 BOX
1	NDC: 13537-043-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-044
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (ROSA 2)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-044-02	1 in 1 BOX
1	NDC: 13537-044-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-045
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (ROSA 3)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-045-02	1 in 1 BOX
1	NDC: 13537-045-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-046
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (ROSA 4)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-046-02	1 in 1 BOX
1	NDC: 13537-046-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-047
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (ROSA 5)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-047-02	1 in 1 BOX
1	NDC: 13537-047-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA   PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-048
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)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
starch, corn (UNII: O8232NY3SJ)
yellow wax (UNII: 2ZA36H0S2V)
calendula officinalis flower (UNII: P0M7O4Y7YD)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
hedera helix top (UNII: 379040L9FW)
phosphoric acid (UNII: E4GA8884NN)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (ROSA 6)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-048-02	1 in 1 BOX
1	NDC: 13537-048-01	2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

Labeler - Ventura Corporation (San Juan, P.R) (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE