ESIKA NATURAL CARE- octinoxate and oxybenzone cream

ESIKA by

Drug Labeling and Warnings

ESIKA 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 7.5%	Sunscreen
OXYBENZONE 4.5%	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

AQUA (WATER), GLYCERYL STEARATE, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, PEG-100 STEARATE, CETYL ALCOHOL, DICAPRYLYL CARBONATE, PROPYLENE GLYCOL, GLYCERIN, PHENOXYETHANOL, CYCLOHEXASILOXANE, DIMETHICONE, METHYLPARABEN, CI 77891 (TITANIUM DIOXIDE ), PAPAIN, TRIETHANOLAMINE, PROPYLPARABEN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM LACTATE, CASTORYL MALEATE, PARFUM (FRAGRANCE), BUTYLENE GLYCOL, TETRASODIUM EDTA, CALCIUM PANTOTHENATE, ARCTOSTAPHYLOS UVA URSI LEAF EXTRACT, XANTHAN GUM, BUTYLPARABEN, ETHYLPARABEN, CAPRYLYL GLYCOL, ROSA MOSCHATA SEED OIL, UREA, MAGNESIUM LACTATE, ETHYLHEXYLGLYCERIN, POTASSIUM LACTATE, ISOBUTYLPARABEN, ALANINE, MAGNESIUM CHLORIDE, PROLINE, SERINE, SODIUM CITRATE, MOTHER OF PEARL EXTRACT.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 60 g Bottle Carton

naturalcare

rosa mosqueta
& concha de nácar

crema aclaradora facial FPS 15

60 g e (2.1 oz.)

ésika

INGREDIENTS AND APPEARANCE

ESIKA   NATURAL CARE
octinoxate and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.045 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PAPAIN (UNII: A236A06Y32)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LACTATE (UNII: TU7HW0W0QT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE SODIUM (UNII: MP1J8420LU)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)
UREA (UNII: 8W8T17847W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM LACTATE (UNII: 87V1KMK4QV)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
ALANINE (UNII: OF5P57N2ZX)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PROLINE (UNII: 9DLQ4CIU6V)
SERINE (UNII: 452VLY9402)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-152-01	1 in 1 CARTON
1		60 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/24/2012

Labeler - Ventura Corporation Ltd (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-152)