LBel by VENTURA INTERNATIONAL LTD., LBEL- octinoxate cream

LBel by

Drug Labeling and Warnings

LBel by is a Otc medication manufactured, distributed, or labeled by VENTURA INTERNATIONAL LTD.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate (4.5 %)

Purpose

Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• provides moderate protection against sunburn

Warnings

• For external use only.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash and irritation develops and lasts.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• moderate sun protection product
• apply smootly every morning before sun exposure and as needed.
• children under 6 months of age: ask a doctor.

Other information

• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

Inactive ingredients

Aqua (water), cyclopentasiloxane, butylene glycol, cyclohexasiloxane, phenyl trimethicone, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, polydodecanamideaminium triazadiphenylethenesulfonate, hexyl laurate, mannitol, glycerin, peg/ppg-18/18 dimethicone, glycine soja (soybean) protein, ethylene/acrylic acid copolymer, sodium chloride, disteardimonium hectorite, dimethicone, propylene glycol, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, diazolidinyl urea, hydrolyzed keratin, dimethiconol, sucrose, methylparaben, serine, parfum (fragance), methicone, arginine, cyclodextrin, polyvinylalcohol crosspolymer, pca, bht, macrocystis pyrifera extract, faex extract (yeast extract), alanine, propylparaben, hydrolyzed wheat protein, pvp, carbomer, polysorbate 20, disodium succinate, palmitoyl pentapeptide-4, threonine, mourera fluviatilis extract. May contain: ci 77891(titanium dioxide), ci 77491, ci 77492, ci 77499 (iron oxides).

SPL UNCLASSIFIED SECTION

US: Distributed by Ventura International, Ltd. San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 30 g Carton

L'BEL

SUPRÉMACIE TEINT

replenhising foundation spf 14

30 g e (1 oz.)

INGREDIENTS AND APPEARANCE

LBEL   SUPREMACIE TEINT
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1.35 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
butylene glycol (UNII: 3XUS85K0RA)
cyclomethicone 6 (UNII: XHK3U310BA)
phenyl trimethicone (UNII: DR0K5NOJ4R)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
dimethicone (UNII: 92RU3N3Y1O)
hexyl laurate (UNII: 4CG9F9W01Q)
mannitol (UNII: 3OWL53L36A)
glycerin (UNII: PDC6A3C0OX)
glycine (UNII: TE7660XO1C)
sodium chloride (UNII: 451W47IQ8X)
hectorite (UNII: 08X4KI73EZ)
propylene glycol (UNII: 6DC9Q167V3)
diazolidinyl urea (UNII: H5RIZ3MPW4)
sucrose (UNII: C151H8M554)
methylparaben (UNII: A2I8C7HI9T)
serine (UNII: 452VLY9402)
arginine (UNII: 94ZLA3W45F)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
yeast (UNII: 3NY3SM6B8U)
alanine (UNII: OF5P57N2ZX)
propylparaben (UNII: Z8IX2SC1OH)
wheat (UNII: 4J2I0SN84Y)
polysorbate 20 (UNII: 7T1F30V5YH)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
threonine (UNII: 2ZD004190S)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-085-63	1 in 1 BOX
1	NDC: 14783-085-64	30 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/15/2010

Labeler - VENTURA INTERNATIONAL LTD., (603192787)