LBEL EFFET PARFAIT DUAL-USE COMPACT YOUTHFUL LOOKING SKIN SPF7- titanium dioxide powder

LBEL EFFET PARFAIT DUAL-USE COMPACT YOUTHFUL LOOKING SKIN SPF7 by

Drug Labeling and Warnings

LBEL EFFET PARFAIT DUAL-USE COMPACT YOUTHFUL LOOKING SKIN SPF7 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 Ingredients

Titanium dioxide 5.0 %

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

talc, mica, zinc stearate, octyldodecyl stearoyl stearate, magnesium stearate, dimethicone/vinyl dimethicone crosspolymer, dimethicone, aqua (water), polyperfluoroisopropyl ether, kaolin, glycerin, olea europaea oil unsaponifiables (olea europaea (olive) oil unsaponifiables), lauryl methacrylate/glycol dimethacrylate crosspolymer, calcium carbonate, magnesium silicate, dicaprylyl ether, methylparaben, propylparaben, magnesium myristate, silica, parfum (fragrance), polyethylene, pisum sativum extract (pisum sativum (pea) extract), algae extract, bht, xanthan gum, polyglyceryl-2 dipolyhydroxystearate. May contain: CI 77891 (titanium dioxide), CI 77492 (iron oxides), CI 77491 (iron oxides), CI 77499 (iron oxides).

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 11 g Compact Carton

EFFET PARFAIT

dual-use compact powder: youthful-looking skin SPF 7

11 g e (.38 oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL EFFET PARFAIT DUAL-USE COMPACT YOUTHFUL LOOKING SKIN SPF7 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-886
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
talc (UNII: 7SEV7J4R1U)
mica (UNII: V8A1AW0880)
zinc stearate (UNII: H92E6QA4FV)
octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)
magnesium stearate (UNII: 70097M6I30)
dimethicone (UNII: 92RU3N3Y1O)
water (UNII: 059QF0KO0R)
kaolin (UNII: 24H4NWX5CO)
glycerin (UNII: PDC6A3C0OX)
olive oil (UNII: 6UYK2W1W1E)
lauryl methacrylate/glycol dimethacrylate crosspolymer (UNII: EX0F4CZ66H)
calcium carbonate (UNII: H0G9379FGK)
magnesium silicate (UNII: 9B9691B2N9)
dicaprylyl ether (UNII: 77JZM5516Z)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
magnesium myristate (UNII: Z1917F0578)
silicon dioxide (UNII: ETJ7Z6XBU4)
high density polyethylene (UNII: UG00KM4WR7)
pea (UNII: W4X7H8GYFM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
xanthan gum (UNII: TTV12P4NEE)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-886-01	1 in 1 BOX
1		11 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/16/2013

Labeler - Ventura International LTD. (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-886)