LBEL- octinoxate, oxybenzone, and titanium dioxide lipstick

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation Ltd., BelStar, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7 % , Oxybenzone 3%., Titanium dioxide 0.8%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

Stop use if skin rash occurs

Inactive ingredients

Octyldodecanol, Caprylic/capric triglyceride, Candelilla Cera (euphorbia cerifera (candelilla) wax), Cera Alba (beeswax), Copernicia Cerifera Cera (copernicia cerifera (carnauba ) wax), Butyrospermum parkii (butyrospermum parkii (shea butter)), Hydrogenated polyisobutene, Silica, Propylparaben, Cera Microcristallina (microcrystalline wax), Aqua (water), Tocopheryl Acetate, Petrolatum, Phospholipids, bht, Parfum (fragrance), Cholesterol, Extracto de crambe maritima, Cetearyl Alcohol, Cetearyl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Glycosphingolipids, Maltodextrin, Zea Mays Starch( zea mays (corn) starch), Phenoxyethanol, Sodium Hyaluronate, Methylparaben, Butylparaben, Ethylparaben, Iisobutylparaben.

SPL UNCLASSIFIED SECTION

USA: Dist. by Ventura International Ltd. San Francisco, CA 94111. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 4 g Carton

EFFET PARFAIT
lip moisturizer SPF 18

4 g e (.14 oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL   EFFET PARFAIT
octinoxate, oxybenzone, and titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-021
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)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-021-02	1 in 1 CARTON
1	NDC: 13537-021-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/10/2011

Labeler - Ventura Corporation Ltd. (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
BelStar, S.A.		880160197	MANUFACTURE