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ESIKA

Ventura Corporation (San Juan, P.R)

ēsika Extreme Moisturizing Lipstick SPF 16


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.)

ESIKA

ESIKA

OCTINOXATE and OXYBENZONE LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-303
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0664 g
OXYBENZONE OXYBENZONE 0.0151 g

Inactive Ingredients

Ingredient Name Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
ETHYLHEXYL PALMITATE
Ceresin
water
TRIDECYL STEARATE
GLYCERIN
Neopentyl Glycol Dicaprate
carnauba wax
KAOLIN
OCTYLDODECANOL
PHENOXYETHANOL
MICROCRYSTALLINE WAX
METHYLPARABEN
petrolatum
PROPYLPARABEN
CHOLESTEROL
SOYBEAN OIL
SHEA BUTTER
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYTOLUENE
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
Tocopherol
MAGNESIUM CHLORIDE
potassium chloride
SODIUM CHLORIDE
SILICON DIOXIDE
FD&C YELLOW NO. 5
D&C RED NO. 7
titanium dioxide
MICA
D&C RED NO. 27
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
COCHINEAL
D&c Red No. 21
FD&C BLUE NO. 1
BISMUTH OXYCHLORIDE
talc
ALUMINUM OXIDE

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-05-17


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