LBEL RENOVANCE JOUR DAYTIME FACE SPF 15 ALL SKIN TYPES- octinoxate, octocrylene, oxybenzone cream

LBEL RENOVANCE JOUR Daytime Face SPF 15 All Skin Types by

Drug Labeling and Warnings

LBEL RENOVANCE JOUR Daytime Face SPF 15 All Skin Types 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 RENOVANCE JOUR Daytime Face Cream SPF 15 All Skin Types

Active Ingredients

OCTINOXATE (7.5%)      
OCTOCRYLENE (5.0%)      
OXYBENZONE (3.0%)

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.
  

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.
  

Inactive Ingredients

Aqua (water), cyclohexasiloxane, soy protein phthalate, c12-15 alkyl benzoate, glycerin, pisum sativum extract (pisum sativum (pea) extract), caprylic/capric triglyceride, cyclopentasiloxane, cetyl alcohol, cetearyl alcohol, isononyl isononanoate, isopropyl myristate, sorbitan stearate, mannitol , glyceryl stearate, potassium cetyl phosphate, dimethicone, propylene glycol, peg-75 stearate, sodium pca, methylparaben, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, phenoxyethanol, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, ceteareth-20, panthenol, propylparaben, dimethiconol, ceteth-20, steareth-20, chlorphenesin, ci 77891 (titanium dioxide), parfum (fragrance), teprenone, butylene glycol, cyclodextrin, tetrasodium edta, peg-40 hydrogenated castor oil, polysorbate 80, ppg-26-buteth-26, serine, urea, hydrolyzed algin, hedera helix extract (hedera helix (ivy) leaf/stem extract), faex extract (yeast extract), magnesium pca, chlorella vulgaris extract, retinyl palmitate, maris aqua (sea water), tocopheryl acetate, algin, zinc pca, bioflavonoids, allantoin, ascorbyl palmitate, saccharomyces/magnesium ferment, acacia senegal gum, disodium succinate, saccharomyces/iron ferment, manganese pca, saccharomyces/copper ferment, saccharomyces/calcium ferment, saccharomyces/silicon ferment, saccharomyces/zinc ferment.

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.

RENOVANCE JOUR
intensive, refining, fortifying and renewing daytime face cream SPF 15 

After the age of 50, your skin reflects certain changes brought about  by the passage of time: increased dullness and loss of density and luminosity

The alternative facial cosmetic treatment

Renovance Jour with Solar Protection Factor (SPF) 15, combines the innovations and scientific advances in cosmetics with the mineral supplements that mature skin needs.  An effective synergy for a unique cosmetic treatment that deeply moisturizes the skin and helps fortify and renew the look of your face.
An effective cosmetic treatment that supports the actions of its ingredients:

• Renovage Complex: helps improve the skin’s appearance of firmness, elasticity and tone that has been lost over time.
• Vitaminerale Boost: complex, rich in vitamins and minerals, which give the skin a fortifying and energizing effect.
• Hydra Chronological System: innovative technology, patented in France, that  gives skin progressive, long-lasting and focused hydration where it needs it most. Its formula also contains soy proteins that give the skin an immediate lift appearance.

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.

• HYPOALLERGENIC PRODUCT
• CLINICALLY TESTED

PRINCIPAL DISPLAY PANEL

L'BEL RENOVANCE JOUR  intensive refining, fortifying and renewing daytime face cream SPF 15 all skin types   50g e (1.7 oz.)     Renovance Jour with Solar Protection Factor (SPF) 15, combines the innovations and scientific advances in cosmetics with the mineral supplements that mature skin needs.  An effective synergy for unique cosmetic treatment that deeply moisturizes the skin and helps fortify and renew the look of your face.

L'BEL RENOVANCE JOUR Daytime Face Cream SPF 15 All Skin Types

INGREDIENTS AND APPEARANCE

LBEL RENOVANCE JOUR DAYTIME FACE SPF 15 ALL SKIN TYPES 
octinoxate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43455-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
PEA (UNII: W4X7H8GYFM)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
MANNITOL (UNII: 3OWL53L36A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-75 STEARATE (UNII: OT38R0N74H)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TEPRENONE (UNII: S8S8451A4O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE SODIUM (UNII: MP1J8420LU)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SERINE (UNII: 452VLY9402)
UREA (UNII: 8W8T17847W)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
YEAST (UNII: 3NY3SM6B8U)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC PIDOLATE (UNII: C32PQ86DH4)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ACACIA (UNII: 5C5403N26O)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43455-0004-0	1 g in 1 POUCH
2	NDC: 43455-0004-1	5 g in 1 JAR
3	NDC: 43455-0004-2	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