ESIKA SILK SKIN SPF 9 (TRANSLUCIDO) - BEIGE- octinoxate and titanium dioxide powder ESIKA SILK SKIN SPF 9 (TERRACOTA) - BEIGE- octinoxate and titanium dioxide powder

ESIKA Silk Skin SPF 9 by

Drug Labeling and Warnings

ESIKA Silk Skin SPF 9 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 INGREDIENT

Active Ingredients	Purpose
Octinoxate (2%)	Sunscreen
Titanium Dioxide (4.4%)	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.

• For external use only.

• Do not use on damaged or broken skin.

• When using this product keep out of eyes. Rinse with water to remove.

• 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 the product in this container from excessive heat and direct sun.

Inactive ingredients

TALC, ZEA MAYS STARCH (ZEA MAYS (CORN) STARCH), CALCIUM CARBONATE, SILICA, ZINC STEARATE, PARAFFINUM LIQUIDUM (MINERAL OIL), MICA, HYDROGEN DIMETHICONE, OCTYLDODECANOL, ALUMINA, METHYLPARABEN, PROPYLPARABEN, CERA MICROCRISTALLINA (MICROCRYSTALLINE WAX), PETROLATUM, PHOSPHOLIPIDS, POLYETHYLENE, CHOLESTEROL, CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), CERA ALBA (BEESWAX), CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA) WAX), POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS.
MAY CONTAIN:
IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499).

SPL UNCLASSIFIED SECTION

Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 15 g Bottle Box (Translucido) - BEIGE

ēsika

Silk Skin
Face Powder SPF 9

Net Weight 0.53 oz. (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Bottle Box (Terracota) - BEIGE

ēsika

Silk Skin
Face Powder SPF 9

Net Weight 0.53 oz. (15 g)

INGREDIENTS AND APPEARANCE

ESIKA SILK SKIN SPF 9   (TRANSLUCIDO) - BEIGE
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-275
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.044 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ZINC STEARATE (UNII: H92E6QA4FV)
MINERAL OIL (UNII: T5L8T28FGP)
MICA (UNII: V8A1AW0880)
OCTYLDODECANOL (UNII: 461N1O614Y)
ALUMINUM OXIDE (UNII: LMI26O6933)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
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: 13537-275-02	1 in 1 BOX
1	NDC: 13537-275-01	15 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 SILK SKIN SPF 9   (TERRACOTA) - BEIGE
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-276
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.044 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ZINC STEARATE (UNII: H92E6QA4FV)
MINERAL OIL (UNII: T5L8T28FGP)
MICA (UNII: V8A1AW0880)
OCTYLDODECANOL (UNII: 461N1O614Y)
ALUMINUM OXIDE (UNII: LMI26O6933)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
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: 13537-276-02	1 in 1 BOX
1	NDC: 13537-276-01	15 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(13537-275, 13537-276)