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

LBEL ESSENTIAL Deep moisturizing and oxygenating SPF 20 normal to dry skin by

Drug Labeling and Warnings

LBEL ESSENTIAL Deep moisturizing and oxygenating SPF 20 normal to dry 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, C12-15 ALKYL BENZOATE, GLYCERYL STEARATE, DIMETHICONE, CYCLOHEXASILOXANE, TAPIOCA STARCH, ISOPROPYL PALMITATE, TOCOPHERYL ACETATE, IMPERATA CYLINDRICA ROOT EXTRACT, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, CETYL ALCOHOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, XANTHAN GUM, PEG-75 STEARATE, CETEARYL ISONONANOATE, FRAGRANCE, DIMETHICONOL, METHYLPROPANEDIOL, CETEARETH-20, CETEARYL ALCOHOL, BHT, PEG-8, TETRASODIUM EDTA, CETETH-20, SACCHAROMYCES LYSATE, STEARETH-20, SILANEDIOL SALICYLATE, SODIUM HYDROXIDE, TROMETHAMINE, METHYL PERFLUOROBUTYL ETHER, CARBOMER, ISODODECANE, CETEARETH-12, CETYL PALMITATE, DISODIUM SUCCINATE, GLUTAMIC ACID, GLYCINE, THREONINE, VALINE, POLYSILICONE-11, DECYL GLUCOSIDE, LINALOOL, d-LIMONENE, HEXYL CINNAMAL, BUTYLPHENYL METHYLPROPIONAL, ALPHA-ISOMETHYLIONONE.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 g Tube Box

L'BEL

ESSENTIAL

deep moisturizing
and oxygenating
cream SPF 20
normal to dry skin

Nt. Wt. 1.7 oz. e (50g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-507
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 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.03 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.06 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
STARCH, TAPIOCA (UNII: 24SC3U704I)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETYL ALCOHOL (UNII: 936JST6JCN)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG-75 STEARATE (UNII: OT38R0N74H)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
EDETATE SODIUM (UNII: MP1J8420LU)
CETETH-20 (UNII: I835H2IHHX)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
STEARETH-20 (UNII: L0Q8IK9E08)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TROMETHAMINE (UNII: 023C2WHX2V)
METHYL PERFLUOROBUTYL ETHER (UNII: H637A50B7U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ISODODECANE (UNII: A8289P68Y2)
CETEARETH-12 (UNII: 7V4MR24V5P)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
GLUTAMIC ACID (UNII: 3KX376GY7L)
GLYCINE (UNII: TE7660XO1C)
THREONINE (UNII: 2ZD004190S)
VALINE (UNII: HG18B9YRS7)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
Limonene, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-507-02	1 in 1 BOX	10/25/2016
1	NDC: 13537-507-01	50 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 13537-507-04	1 in 1 BOX	10/25/2016
2	NDC: 13537-507-03	5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 13537-507-06	1 in 1 CARTON	10/25/2016
3	NDC: 13537-507-05	1 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 13537-507-08	1 in 1 CARTON	10/25/2016
4	NDC: 13537-507-07	0.25 g 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	10/25/2016

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-507)