ESSENTIAL SHOCKEYE AND LIP- avobenzone, homosalate, octinocate, octocrylene, oxybenzone cream

Essential Shockeye and Lip by

Drug Labeling and Warnings

Essential Shockeye and Lip by is a Otc medication manufactured, distributed, or labeled by Natura Bisse International, S.A., 464431576. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Avobenzone (Butyl Methoxydibenzoymethane) 3 percent. Homosalate 10 percent. Octinoxate (Ethylhexyl Methoxycinnamate) 4 percent. Octocrylene 2.5 percent. Oxybenzone (Benzophenone-3) 1 percent.

INACTIVE INGREDIENT

Other Ingredients: Water. Glycerin. Polyglyceryl-2 Dipolyhydroxystearate. Dimethicone. Beeswax (cera Alba). Polyglyceryl-4 Isostearate. Cetearyl Ethylhexanoate. Butylene Glycol. C12-15 Alkyl Benzoate. Rosa Canina Fruit Oil. Benxotriazolil Dodecil. Hydrolyzed Collagen. Silybum Marianum Extract. Iris Florentina Root Extract. Ananas Saticus (Pineapple) Fruit Extract. Glycine Soja (Soybean) Germ Extract. Triticum Vulgare (Wheat) Germ Extract. Proppylene Glycol. PEG-60 Hydrogenated Castor Oil. Alcohol Denat. Epsom Salt (Magnesium Sufate. Retinol.  Tocopheryl Acetate. Ascorbyl Palmitate. Disodium Edta. BHT. Phynoxyethanol. Methylparaben. Ethylparaben. Butylparaben. Propylparaben. Isobutylparaben. Fragrance (Parfum). Yellow 5 (CI 19140).

PURPOSE

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection.
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Moderate sun protection product.

PRINCIPAL DISPLAY PANEL

Natura Bisse
Barcelona
Essential Shock Eye and Lip Treatment
Nourishing eye and lip firming cream with sunscreen
Net wt. 0.5 oz. 15 ml.
This product can be sold only by authorized Natura Bisse retailers
Made in Spain by
Natura Bisse Int. S.A.
Cerdanyola - 08290 Barcelina
C.P. 11590 Mexico, D.F. RFC NBI0402132P0
Not tested on animals

INGREDIENTS AND APPEARANCE

ESSENTIAL SHOCKEYE AND LIP 
avobenzone, homosalate, octinocate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63730-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	454 mg  in 15 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	1.44 mL  in 15 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.60 mL  in 15 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.36 mL  in 15 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	151 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
MILK THISTLE (UNII: 822I9LEJ7S)
PINEAPPLE (UNII: 2A88ZO081O)
SOYBEAN (UNII: L7HT8F1ZOD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
RETINOL (UNII: G2SH0XKK91)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	yellow (FD&C YELLOW NO. 5)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63730-204-01	15 mL in 1 TUBE
2	NDC: 63730-204-02	1.5 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/04/2010

Labeler - Natura Bisse International, S.A. (464431576)

Registrant - Natura Bisse International, S.A. (464431576)

Establishment
Name	Address	ID/FEI	Business Operations
464431576		464431576	manufacture