LBEL EFFET PARFAIT LIP MOISTURIZER SPF 18 FM HIDRATANTE PARA LABIOS FPS 18 FM- octinoxate, oxybenzone, and titanium dioxide lipstick

LBEL EFFET PARFAIT Lip moisturizer SPF 18 FM Hidratante para labios FPS 18 FM by

Drug Labeling and Warnings

LBEL EFFET PARFAIT Lip moisturizer SPF 18 FM Hidratante para labios FPS 18 FM by is a Otc medication manufactured, distributed, or labeled by Ventura International 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 7.00 %	Sunscreen
OXYBENZONE 3.00 %	Sunscreen
TITANIUM DIOXIDE 0.80 %	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 damage 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.
• Children under 6 months of age: Ask a doctor.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil.

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

OCTYLDODECANOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, EUPHORBIA CERIFERA (CANDELILLA) WAX, SYNTHETIC BEESWAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, COPERNICIA CERIFERA (CARNAUBA) WAX, HYDROGENATED POLYISOBUTENE, SILICA, MICROCRYSTALLINE WAX, PHENOXYETHANOL, TOCOPHERYL ACETATE, PETROLATUM, PHOSPHOLIPIDS, CAPRYLYL GLYCOL, FRAGRANCE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, CHLORPHENESIN, CHOLESTEROL, CRAMBE MARITIMA EXTRACT, BEESWAX, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Int Ltd. DBA
Belcorp USA, Miami, FL 33126.

PRINCIPAL DISPLAY PANEL - 4 g Tube Box

L'BEL

EFFET
PARFAIT

lip moisturizer
SPF 18 FM

Net Weight 0.14 oz. (4 g)

INGREDIENTS AND APPEARANCE

LBEL EFFET PARFAIT LIP MOISTURIZER SPF 18 FM HIDRATANTE PARA LABIOS FPS 18 FM 
octinoxate, oxybenzone, and titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-865
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.03 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.008 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CANDELILLA WAX (UNII: WL0328HX19)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
CHLORPHENESIN (UNII: I670DAL4SZ)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-865-02	1 in 1 BOX
1	NDC: 14783-865-01	4 g in 1 TUBE; 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	12/08/2015

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-865)