ESIKA- octinoxate and oxybenzone lipstick

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

Octinoxate 6.64%, Oxybenzone 1.51%

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 lipstick following the curves of natural lip line.

Inactive Ingredients

Dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, ethylhexyl palmitate, ozokerite, polyethylene, polymethyl methacrylate, aqua (water), polyglyceryl-3 diisostearate, tridecyl stearate, glycerin, neopentyl glycol dicaprylate/dicaprate, copernicia cerifera cera (copernicia cerifera (carnauba ) wax), kaolin, octyldodecanol , phenoxyethanol, sodium starch octenylsuccinate, tocopheryl acetate, microcristallina cera (microcrystalline wax), parfum (fragrance), methylparaben, petrolatum, phospholipids, propylparaben, cholesterol, glycine soja oil (glycine soja (soybean) oil), butyrospermum parkii butter (butyrospermum parkii (shea) butter), butylparaben, ethylparaben, bht, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, tocopherol, glycosphingolipids, magnesium chloride, potassium chloride, sodium chloride, silica, ci 19140 (yellow 5 lake), ci 15850 (red 7 lake), ci 77891 (titanium dioxide), ci 77019 (mica), ci 45410 (red 27 lake), ci 77491 (iron oxides), ci 77492 (iron oxides), ci 77499 (iron oxides), ci 75470 (carmine), ci 45380 (red 21 lake), ci 42090 (blue 1 lake), ci 77163 (bismuth oxychloride), chitosan, talc.

PRINCIPAL DISPLAY PANEL - 4 g Carton

ēsika

Extreme
Moisturizing Lipstick
SPF 16

4 g e (.14 oz.)

INGREDIENTS AND APPEARANCE

ESIKA   EXTREME MOISTURIZING SPF 16
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0664 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
TRIDECYL STEARATE (UNII: A8OE252M6L)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
CARNAUBA WAX (UNII: R12CBM0EIZ)
KAOLIN (UNII: 24H4NWX5CO)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SOYBEAN OIL (UNII: 241ATL177A)
SHEA BUTTER (UNII: K49155WL9Y)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
COCHINEAL (UNII: TZ8Z31B35M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-303-02	1 in 1 BOX
1	NDC: 13537-303-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

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

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