LBel by VENTURA INTERNATIONAL LTD., LBEL- octinoxate lotion

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 7.0 %

Purpose

sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection
• Provides minimal 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 or irritation develops and lasts.

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

Directions

• Apply liberally before sun exposure and as needed.

Other information

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

Inactive ingredients

aqua (water), cyclomethicone, cyclopentasiloxane, cyclohexasiloxane, sodium chloride, peg/ppg-18/18 dimethicone, dimethicone, nylon-12 fluorescent brightener 230 salt, dimethiconol, diazolidinyl urea, methicone, cetearyl dimethicone crosspolymer, methylparaben, parfum (fragrance), propylparaben, polyvinylalcohol crosspolymer, sodium hyaluronate. May contain: ci77891 (titanium dioxide), ci77492 (iron oxides), ci77491 (iron oxides), ci77499 (iron oxides).

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

L'BEL

EFFET
PARFAIT

filling effect
foundation spf 10

30 ml e (1 fl.oz.)

INGREDIENTS AND APPEARANCE

LBEL   EFFET PARFIT
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	2.1 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
dimethicone (UNII: 92RU3N3Y1O)
diazolidinyl urea (UNII: H5RIZ3MPW4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
hyaluronate sodium (UNII: YSE9PPT4TH)
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: 13537-230-62	1 in 1 BOX
1	NDC: 13537-230-61	30 mL in 1 BOTTLE

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., (602751344)