LBEL ESSENTIAL DEEP MOISTURIZING AND OXYGENATING SPF 20 NORMAL TO OILY SKIN- avobenzone, octinoxate, octisalate, and octocrylene lotion

LBEL ESSENTIAL deep moisturizing and oxygenating SPF 20 normal to oily skin by

Drug Labeling and Warnings

LBEL ESSENTIAL deep moisturizing and oxygenating SPF 20 normal to oily skin 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
AVOBENZONE (3.00 %)	Sunscreen
OCTINOXATE (3.00 %)	Sunscreen
OCTISALATE (5.00 %)	Sunscreen
OCTOCRYLENE (6.00 %)	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

WATER, GLYCERIN, BUTYLENE GLYCOL, ALUMINUM STARCH OCTENYLSUCCINATE, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, CETEARYL ALCOHOL, DIMETHICONE, TOCOPHERYL ACETATE, GLYCERYL STEARATE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, CETYL ALCOHOL, CETEARETH-20, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, FRAGRANCE, XANTHAN GUM, PEG-75 STEARATE, ENANTIA CHLORANTHA BARK EXTRACT, METHYLPROPANEDIOL, BHT, TETRASODIUM EDTA, SACCHAROMYCES LYSATE, CETETH-20, STEARETH-20, SILANEDIOL SALICYLATE, SODIUM HYDROXIDE, TROMETHAMINE, METHYL PERFLUOROBUTYL ETHER, ISODODECANE, DISODIUM SUCCINATE, SILICA, GLUTAMIC ACID, GLYCINE, THREONINE, VALINE , POLYSILICONE-11, OLEANOLIC ACID, BLUE 1, DECYL GLUCOSIDE.

SPL UNCLASSIFIED SECTION

PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan,
Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Box

L'BEL

ESSENTIAL

deep moisturizing
and oxygenating
lotion SPF 20
normal to oily skin

50 ml e (1.6 fl.oz.)

INGREDIENTS AND APPEARANCE

LBEL ESSENTIAL DEEP MOISTURIZING AND OXYGENATING SPF 20 NORMAL TO OILY SKIN 
avobenzone, octinoxate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-637
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.03 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.06 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG-75 STEARATE (UNII: OT38R0N74H)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE SODIUM (UNII: MP1J8420LU)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TROMETHAMINE (UNII: 023C2WHX2V)
METHYL PERFLUOROBUTYL ETHER (UNII: H637A50B7U)
ISODODECANE (UNII: A8289P68Y2)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLUTAMIC ACID (UNII: 3KX376GY7L)
GLYCINE (UNII: TE7660XO1C)
THREONINE (UNII: 2ZD004190S)
VALINE (UNII: HG18B9YRS7)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-637-02	1 in 1 BOX
1	NDC: 13537-637-01	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 13537-637-04	1 in 1 BOX
2	NDC: 13537-637-03	5 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 13537-637-06	1 in 1 CARTON
3	NDC: 13537-637-05	1 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 13537-637-08	1 in 1 CARTON
4	NDC: 13537-637-07	0.25 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	03/09/2015

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-637)