LBEL REGRESSION JOUR PROTECTIVE COMPLEX WITH SPF 15 FACIAL DAY NORMAL TO COMBINATION SKIN- octinoxate, octisalate, oxybenzone lotion

LBEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Normal to Combination Skin by

Drug Labeling and Warnings

LBEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Normal to Combination 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 REGRESSION JOUR Protective Complex With SPF 15 Facial Day Lotion Normal to Combination Skin

Active Ingredients

Octinoxate (7.5%)
Octisalate (4%)
Oxybenzone (4%)

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.
• Apply after cleansing and toning on face and neck
• 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.
• Apply in the morning at the end of your skin care routine.
• Apply with the fingertips, spreading softly throughout the face until completely absorbed
  

Inactive Ingredients

AQUA (WATER), GLYCINE SOJA PROTEIN (GLYCINE SOJA (SOYBEAN) PROTEIN), C12-15 ALKYL BENZOATE, PISUM SATIVUM EXTRACT (PISUM SATIVUM (PEA) EXTRACT), CYCLOHEXASILOXANE, DIMETHICONE, MANNITOL, CETEARYL ALCOHOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PHENOXYETHANOL, SODIUM ACRYLATE/ACRYLOYLDIMETHYLTAURATE/DIMETHYLACRYLAMIDE CROSSPOLYMER, C20-22 ALKYL PHOSPHATE, GLYCERYL STEARATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDYMETHYL TAURATE COPOLYMER, C20-22 ALCOHOLS, TRIETHANOLAMINE, ISOHEXADECANE, METHYLPARABEN, C14-22 ALCOHOLS,CETEARYL GLUCOSIDE, HYDROLYZED ADANSONIA DIGITATA EXTRACT, BUTYLPARABEN, CYCLOPENTASILOXANE, CHLORPHENESIN, XANTHAN GUM, PROPYLPARABEN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, PARFUM (FRAGRANCE), SORBIC ACID, POLYSORBATE 60, CYCLODEXTRIN, C12-20  ALKYL  GLUCOSIDE, FAEX EXTRACT (YEAST EXTRACT), HYDROLYZED ALGIN, ETHYLPARABEN, CHLORELLA VULGARIS EXTRACT, MARIS AQUA (SEA WATER), ISOBUTYLPARABEN, SILICA, DISODIUM SUCCINATE, CI 42090 (BLUE  1)

Purpose

Sunscreen

Call us toll-free: In the United States at 1-800-992-LBEL (5235), in Puerto Rico, 1-866-366-3235 (Metro area). US: Dis. by Ventura International Ltd.

US:  Dis. 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

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. Noursih according to age

PROGRESSION JOUR
Protective complex with SPF 15

The skin is an organ that acts as the body's first line of defense against environmental aggressions.  However, after the age of 30, the skin's natural self-defense properties diminish, making it more vulnerable to ultraviolet (UVA and UVB) rays, as well as to pollution, which can accelerate the aging process.

The skin does not recover as quickly as it once did.  For that reason, it is essential to give your skin the protection it needs.

Regression Jour with Sun Protection Factor (SPF) 15, in addition to moisturizing the skin, acts as a shield to protect its youthful appearance.

Discover the effectiveness of its action

• Protective Shield Complex:  Effective plant-derived complex that helps maintain the skin's natural defenses.
• Hydra-Film Technology:  Seaweed extract that helps recover the skin's hydrolipid layer - responsible for hydration, absorption and water retention - to transport moisture to the skin cells that need it most.

In two options according to your skin's needs:

• Regression Jour protective complex with SPF 15 facial day cream normal to dry skin.
• Regression Jour protective complex with SPF 15 facial day cream normal to combination 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.
• Apply after cleansing and toning on face and neck
• 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.
• Apply in the morning at the end of your skin care routine
• Apply with fingertips, spreading softly throughout the face until completely absorbed
• HYPOALLERGENIC
• CLINICALLY AND DERMATOLOGICALLY TESTED
  

PRINCIPAL DISPLAY PANEL

After the age of 30

NEW REGRESSION JOUR Protective complex with SPF 15 facial day lotion normal to combination skin 50 ml e (1.6 fl. oz.)    L'BEL

L'BEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Lotion Normal to Combination Skin

INGREDIENTS AND APPEARANCE

LBEL REGRESSION JOUR PROTECTIVE COMPLEX WITH SPF 15 FACIAL DAY NORMAL TO COMBINATION SKIN 
octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43455-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SOY PROTEIN (UNII: R44IWB3RN5)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PEA (UNII: W4X7H8GYFM)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
MANNITOL (UNII: 3OWL53L36A)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
TROLAMINE (UNII: 9O3K93S3TK)
ISOHEXADECANE (UNII: 918X1OUF1E)
METHYLPARABEN (UNII: A2I8C7HI9T)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBIC ACID (UNII: X045WJ989B)
POLYSORBATE 60 (UNII: CAL22UVI4M)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
YEAST (UNII: 3NY3SM6B8U)
ETHYLPARABEN (UNII: 14255EXE39)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
D&C BLUE NO. 4 (UNII: 0KSY80VYS3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43455-0003-0	1 mL in 1 POUCH
2	NDC: 43455-0003-1	5 mL in 1 JAR
3	NDC: 43455-0003-2	50 mL 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