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

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.

----------

ESIKA 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, 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 (copernicia cerifera (carnauba) wax), polymethyl methacrylate, zea mays starch (zea mays (corn) starch), cera alba (beeswax), helianthus annuus seed oil (helianthus annuus (sunflower) seed oil), phenoxyethanol, calendula officinalis flower extract, methylparaben, dimethicone, parfum (fragrance), peg-40 hydrogenated castor oil, polysorbate 80, ppg-26-buteth-26, butylparaben, c9-13 fluoroalcohol, ethylparaben, hedera helix extract leaf/stem (hedera helix (ivy) leaf/stem extract), trimethylsiloxysilicate, retinyl palmitate, phosphoric acid, tocopheryl acetate, isobutylparaben, propylparaben, bioflavonoids, allantoin, ascorbyl palmitate.

May contain

Net Weight 0.07 oz. (2 g)

Principal Display Panel - 2 g Bottle Box - (Rosa 6) - PINK

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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 LABEL	Item Code (Source)	NDC:13537-210
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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 LABEL	Item Code (Source)	NDC:13537-211
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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 LABEL	Item Code (Source)	NDC:13537-212
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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 LABEL	Item Code (Source)	NDC:13537-213
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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 LABEL	Item Code (Source)	NDC:13537-214
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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 LABEL	Item Code (Source)	NDC:13537-215
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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 LABEL	Item Code (Source)	NDC:13537-216
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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 LABEL	Item Code (Source)	NDC:13537-217
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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 LABEL	Item Code (Source)	NDC:13537-218
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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 LABEL	Item Code (Source)	NDC:13537-219
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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 LABEL	Item Code (Source)	NDC:13537-221
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Ethylhexyl palmitate
alkyl (C12-15) benzoate
medium-chain triglycerides
mica
di-ppg-3 myristyl ether adipate
sorbitan isostearate
high density polyethylene
carnauba wax
starch, corn
sunflower oil
phenoxyethanol
calendula officinalis flower
methylparaben
dimethicone
polyoxyl 40 hydrogenated castor oil
polysorbate 80
ppg-26-buteth-26
butylparaben
ethylparaben
hedera helix leaf
vitamin a palmitate
phosphoric acid
.alpha.-tocopherol acetate
isobutylparaben
propylparaben
allantoin
ascorbyl palmitate
ferric oxide yellow
ferric oxide red
ferrosoferric oxide

#	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)

Revised: 12/2013

Document Id: b2da04c5-8afc-4027-804e-14174d7bd6b3

Set id: d59348d1-8c8b-403b-bc10-4e5fade9ca79

Version: 1

Effective Time: 20131220

Ventura Corporation LTD