DailyMed - 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)

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.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-209-02	1 in 1 BOX
1	NDC:13537-209-01	2 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-210-04	1 in 1 BOX
1	NDC:13537-210-03	2 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-211-06	1 in 1 BOX
1	NDC:13537-211-05	2 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-212-08	1 in 1 BOX
1	NDC:13537-212-07	2 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-213-10	1 in 1 BOX
1	NDC:13537-213-09	2 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-214-12	1 in 1 BOX
1	NDC:13537-214-11	2 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-215-14	1 in 1 BOX
1	NDC:13537-215-13	2 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-216-16	1 in 1 BOX
1	NDC:13537-216-15	2 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-217-18	1 in 1 BOX
1	NDC:13537-217-17	2 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-218-20	1 in 1 BOX
1	NDC:13537-218-19	2 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-219-22	1 in 1 BOX
1	NDC:13537-219-21	2 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-221-24	1 in 1 BOX
1	NDC:13537-221-23	2 g in 1 BOTTLE, PLASTIC

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

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
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)

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Published Date (What is this?)	Version	Files
Apr 10, 2014	2 (current)	download
Dec 24, 2013	1	download

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	NDC
1	13537-209-01
2	13537-209-02 (inactivated)
3	13537-210-03
4	13537-210-04 (inactivated)
5	13537-211-05
6	13537-211-06 (inactivated)
7	13537-212-07
8	13537-212-08 (inactivated)
9	13537-213-09
10	13537-213-10 (inactivated)
11	13537-214-11
12	13537-214-12 (inactivated)
13	13537-215-13
14	13537-215-14 (inactivated)
15	13537-216-15
16	13537-216-16 (inactivated)
17	13537-217-17
18	13537-217-18 (inactivated)
19	13537-218-19
20	13537-218-20 (inactivated)
21	13537-219-21
22	13537-219-22 (inactivated)
23	13537-221-23
24	13537-221-24 (inactivated)

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Number of versions: 2

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.