ESIKA- octinoxate and titanium dioxide powder ESIKA- octinoxate and titanium dioxide powder

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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate (2%), Titanium Dioxide (4.43%)

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.
• Provides minimum protection against sunburn

Warnings

• For external use only

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

• Stop use and ask a doctor if rash and irritation develops and lasts.

• Children under 6 months of age: ask a doctor.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply smootly every morning before sun exposure and as needed.
• Sun protection product.

Other information

• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Talc, zea mays starch( zea mays (corn) starch), calcium carbonate, silica, zinc stearate, paraffinum liquidum (mineral oil), CI 77019 (mica), dimethicone/methicone copolymer, octyldodecanol, alumina, methylparaben, propylparaben, microcristallina cera (microcrystalline wax), petrolatum, phospholipids, polyethylene, cholesterol, polyglyceryl-2 dipolyhydroxystearate, copernicia cerifera cera (copernicia cerifera (carnauba) wax), candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl glucoside, cetearyl alcohol, glycosphingolipids. May contain: CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides).

PRINCIPAL DISPLAY PANEL - 15 g Carton (Translucido)

ēsika

Silk Skin
Face Powder SPF 9

15 g e (.53 oz.)

PRINCIPAL DISPLAY PANEL - 15 g Carton (Terracota)

ēsika

Silk Skin
Face Powder SPF 9

15 g e (.53 oz.)

INGREDIENTS AND APPEARANCE

ESIKA   SILK SKIN TRANSLUCIDO
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-354
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)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-354-02	1 in 1 BOX
1	NDC: 13537-354-01	15 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	07/24/2011

ESIKA   SILK SKIN TERRACOTA
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-355
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)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-355-02	1 in 1 BOX
1	NDC: 13537-355-01	15 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	07/24/2011

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

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