LBEL SUPREMACIE NX JOUR Replenishing Daytime Face SPF 15 Normal To Oily Skin: Package Insert and Label Information

LBEL SUPREMACIE NX JOUR REPLENISHING DAYTIME FACE SPF 15 NORMAL TO OILY SKIN — ensulizole, homosalate, octinoxate, oxybenzone and titanium dioxide cream
Ventura Corporation, LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

L’BEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face Cream SPF 15 Normal To Oily Skin

Active Ingredients

ENSULIZOLE (1.50%)
HOMOSALATE (1.00%)
OCTINOXATE (7.50%)
OXYBENZONE (4.50%)
TITANIUM DIOXIDE (1.17%)

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 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), cyclopentasiloxane, c12-15 alkyl benzoate, pisum sativum extract (pisum sativum (pea) extract), cyclohexasiloxane, triethanolamine, cetyl alcohol, glycerin, glyceryl stearate, propylene glycol, methyl methacrylate crosspolymer, peg-75 stearate, phenoxyethanol, erythritol, sodium polystyrene sulfonate, xanthan gum, parfum (fragrance), trifolium pratense flower extract (trifolium pratense (clover) flower extract), acrylates/c10-30 alkyl acrylate crosspolymer, ceteth-20, sorghum bicolor stalk juice, steareth-20, methylparaben, silica, methicone, butylparaben,dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, stearic acid, chlorphenesin, butylene glycol, sorbic acid, tetrasodium edta, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydrolyzed algin, ethylparaben, dimethiconol, squalane, chlorella vulgaris extract, lecithin, maris aqua (sea water), isobutylparaben, propylparaben, carbomer, polysorbate 60, homarine hcl, ci 19140 (yellow 5), biotinoyl tripeptide-1, ci 14700 (red 4).

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


  • 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

L’BEL


replenishing daytime face cream SPF 15
normal to oily skin
50 ml e (1.6 fl.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

L’BEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face Cream SPF 15 Normal To Oily Skin

Supremacie NX Jour
(click image for full-size original)
Supremacie NX Jour 50 ml
(click image for full-size original)
Supremacie NX Jour 50 ml A
(click image for full-size original)
LBEL SUPREMACIE NX JOUR REPLENISHING DAYTIME FACE SPF 15 NORMAL TO OILY SKIN ensulizole, homosalate, octinoxate, oxybenzone, titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0006
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 1.5 mL in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 1 mL in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 4.5 mL in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.17 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
ALKYL (C12-15) BENZOATE
PEA
CYCLOMETHICONE 6
TROLAMINE
CETYL ALCOHOL
GLYCERIN
GLYCERYL MONOSTEARATE
PROPYLENE GLYCOL
PEG-75 STEARATE
PHENOXYETHANOL
ERYTHRITOL
SODIUM POLYSTYRENE SULFONATE
XANTHAN GUM
TRIFOLIUM PRATENSE FLOWER
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)
CETETH-20
SORGHUM BICOLOR STEM JUICE
STEARETH-20
METHYLPARABEN
SILICON DIOXIDE
BUTYLPARABEN
DIMETHICONE
STEARIC ACID
CHLORPHENESIN
BUTYLENE GLYCOL
SORBIC ACID
EDETATE SODIUM
ETHYLPARABEN
SQUALANE
CHLORELLA VULGARIS
ISOBUTYLPARABEN
PROPYLPARABEN
POLYSORBATE 60
FD&C YELLOW NO. 5
BIOTINOYL TRIPEPTIDE-1
FD&C RED NO. 4
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43596-0006-0 1 mL in 1 POUCH None
2 NDC:43596-0006-1 5 mL in 1 TUBE None
3 NDC:43596-0006-2 50 mL in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 03/28/2012
Labeler — Ventura Corporation, LTD (602751344)
Establishment
Name Address ID/FEI Operations
MF Productions 266769145 manufacture

Revised: 03/2012 Ventura Corporation, LTD

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