LBEL- octinoxate and oxybenzone lipstick

LBEL by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Octinoxate 7.1 % , Oxybenzone 1.6%

Purpose

sunscreen

Uses

Helps prevent sunburn

Warnings

Stop use if skin rash occurs

Inactive ingredients

ethylhexyl palmitate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, polyethylene, polymethyl methacrylate, (butyrospermum parkii (shea butter), ozokerite, copernicia cerifera (carnauba) wax, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, octyldodecanol, disteardimonium hectorite, caprylic/capric triglyceride, phenoxyethanol, tocopheryl acetate, aloe barbadensis leaf extract, fragrance, microcrystalline wax, propylene carbonate, silica, methylparaben, petrolatum, phospholipids, bht, cholesterol, butylparaben, ethylparaben, crambe maritima extract, bha, euphorbia cerifera (candelilla) wax, beeswax, polyglyceryl-2 dipolyhydroxystearate, cetearyl glucoside, cetearyl alcohol, propylparaben, isobutylparaben, glycosphingolipids. May contain: mica, titanium dioxide, red 7 lake, iron oxides, yellow 5 lake, red 30 lake, red 21 lake, bismuth oxychloride, talc, red 40 lake, blue 1 lake, carmine, hydrogenated polyisobutene, palmitic acid.

SPL UNCLASSIFIED SECTION

USA: Dist. by Ventura International Ltd. San Francisco, CA 94111. Made in Colombia. PUERTO RICO: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 4 g Carton

COULEUR LUXE ROUGE IRRÉSISTIBLE

maximum hydration lipstick SPF 17

4 g e (.14 oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL   COULEUR LUXE ROUGE IRRESISTIBLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-990
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SHEA BUTTER (UNII: K49155WL9Y)
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 21 (UNII: 08744Z6JNY)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
TALC (UNII: 7SEV7J4R1U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C BLUE NO. 4 (UNII: 0KSY80VYS3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-990-05	12 in 1 CARTON
1	NDC: 14783-990-04	4 g in 1 TUBE
2	NDC: 14783-990-12	12 in 1 CARTON
2	NDC: 14783-990-11	11.4 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/26/2010

Labeler - Ventura International, Limited (603192787)

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