LBEL SUPREMACIE NX JOUR REPLENISHING TREATMENT DAYTIME FACE SPF 15 NORMAL TO DRY SKIN- ensulizole, homosalate, octinoxate, oxybenzone cream

LBEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face SPF 15 Normal To Dry Skin by

Drug Labeling and Warnings

LBEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face SPF 15 Normal To Dry Skin by is a Otc medication manufactured, distributed, or labeled by Ventura International, LTD, MF Productions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

L'BEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face Cream SPF 15 Normal To Dry Skin

Active Ingredients

ENSULIZOLE (2.0%)
HOMOSALATE (2.0%)
OCTINOXATE (7.5%)
OXYBENZONE (4.0%)

Uses

• Helps prevent sunburn.

Warnings

• Skin Cancer / Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
• 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 occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 years.
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age:  Ask a doctor.
  

Other Information

• Protect the product in this container from excessive heat and direct sun.
• Use in the morning after cleanser and toner. Apply a small quantity with your fingertips, spreading it over your face with rising, circular movements. Message in gently to help facilitate absorption.
  

Inactive Ingredients

Aqua (water), pisum sativum extract (pisum sativum (pea) extract), glycerin, cetyl alcohol, cyclopentasiloxane, triethanolamine, c12-15 alkyl benzoate, cyclohexasiloxane, glyceryl stearate, stearic acid, phenoxyethanol,polyacrylamide, erythritol,parfum (fragrance), peg-75 stearate, sodium polystyrene sulfonate,methylparaben, trifolium pratense flower extract(trifolium pratense (clover) flower extract), c13-14 isoparaffin,sorghum bicolor stalk juice, propylparaben, xanthan gum, ceteth-20,steareth-20, butylene glycol, laureth-7, acrylates/c10-30 alkyl acrylate crosspolymer, tetrasodium edta, dimethicone, butylparaben, hydrolyzed algin, ethylparaben, chlorella vulgaris extract, lecithin,  maris aqua (sea water), isobutylparaben, carbomer, laureth-23, laureth-4, homarine hcl, ci 19140 (yellow 5),ci 14700 (red 4), biotinoyl tripeptide-1, ci 42090 (blue 1).

Purpose

Sunscreen

EXPERT ROUTINE L'BEL

L'Bel presents Expert Routine, a skin care program with two steps that work together for enhanced results:

   1. Cleanse the skin according to its needs
   2. Nourish according to the age.

SUPREMACIE NX JOUR
replenishing daytime face cream SPF 15

L'Bel, fully specialized in cosmetic facial treatment, presents the latest worldwide exclusive:  the new Supremacie NX line of replenishing cosmetic treatments improved for women after age 40.

Dazzling beauty for women

The moisturizing formula of Supremacie NX Jour, Offers enhanced results:

• Immediate, strong and long-lasting hydration in the areas where the face needs it most.
• Visibly diminishes the appearance of wrinkles.
• Uncovers skin that looks more firm.

A sensation of well-being that pervades the senses

Its rich and creamy texture, ideal for absorption has been specially created to provide a pleasant sensation of softness and comfort. Its exquisite fragrance rich in essences awakens the skin with new and pleasant emotions.

In two options according to your skin's needs:

•  SUPREMACIE NX JOUR - replenishing daytime face cream SPF 15 Normal to Dry Skin

•  SUPREMACIE NX JOUR - replenishing daytime face cream SPF 15 Normal to Oily Skin

USES: Helps prevent sunburn.

WARNINGS: Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions: Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours.Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age:  Ask a doctor.

Other information: Protect the product in this container from excessive heat and direct sun. Use in the morning after cleanser and toner. Apply a small quantity with your fingertips, spreading it over your face with rising, circular movements. Message in gently to help facilitate absorption.

• HYPOALLERGENIC
• DERMATOLOGICALLY AND CLINICALLY TESTED

PRINCIPAL DISPLAY PANEL

L'BEL
SUPREMACIE NX JOUR

replenishing daytime face cream SPF 15
normal to dry skin

50 g e (1.7 oz..)

US: Dist. by Ventura International Ltd.  DBA Belcorp USA, San Francisco, CA 94111.

P.R.: Dist. by Ventura Corporation Ltd. San Juan, Puerto Rico 00926  MADE IN FRANCE.

LBEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face Cream SPF 15 Normal To Dry Skin

INGREDIENTS AND APPEARANCE

LBEL SUPREMACIE NX JOUR REPLENISHING TREATMENT DAYTIME FACE SPF 15 NORMAL TO DRY SKIN 
ensulizole, homosalate, octinoxate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43455-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEA (UNII: W4X7H8GYFM)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TROLAMINE (UNII: 9O3K93S3TK)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ERYTHRITOL (UNII: RA96B954X6)
PEG-75 STEARATE (UNII: OT38R0N74H)
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
SORGHUM BICOLOR STEM JUICE (UNII: SKN30A294R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LAURETH-7 (UNII: Z95S6G8201)
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)
EDETATE SODIUM (UNII: MP1J8420LU)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
LAURETH-23 (UNII: N72LMW566G)
LAURETH-4 (UNII: 6HQ855798J)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43455-0005-0	1 g in 1 POUCH
2	NDC: 43455-0005-1	5 g in 1 JAR
3	NDC: 43455-0005-2	50 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/28/2012

Labeler - Ventura International, LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
MF Productions		266769145	manufacture