LBEL REGRESSION JOUR PROTECTIVE COMPLEX WITH SPF 15 FACIAL DAY NORMAL TO DRY SKIN- avobenzone, ensulizole, octinoxate, and oxybenzone cream

LBEL REGRESSION JOUR by

Drug Labeling and Warnings

LBEL REGRESSION JOUR by is a Otc medication manufactured, distributed, or labeled by Ventura International Ltd., MF Productions Saumur (France). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone (2 %)	Sunscreen
Ensulizole (1 %)	Sunscreen
Octinoxate (7.5 %)	Sunscreen
Oxybenzone (2 %)	Sunscreen

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), propylene glycol, cyclopentasiloxane, cetyl alcohol, c12-15 alkyl benzoate, pisum sativum extract (pisum sativum (pea) extract), cyclohexasiloxane, triethanolamine, glyceryl stearate, mannitol, corn starch modified, phenoxyethanol, polyacrylamide, hydrolyzed adansonia digitata extract,stearic acid, peg-75 stearate, methylparaben, c13-14 isoparaffin, propylparaben, xanthan gum, parfum (fragrance), ceteth-20, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, steareth-20, acrylates/c10-30 alkyl acrylate crosspolymer, disodium edta, laureth-7, cyclodextrin, dimethicone crosspolymer, dimethicone, faex extract (yeast extract), hydrolyzed algin, butylparaben, ethylparaben, chlorella vulgaris extract, isobutylparaben, maris aqua (sea water), laureth-23, laureth-4, disodium succinate, CI 42090 (blue 1)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 5 g Jar Box

L'BEL

REGRESSION JOUR

protective complex with SPF 15
facial day cream
normal to dry skin

5 g e (.17 oz.)

INGREDIENTS AND APPEARANCE

LBEL REGRESSION JOUR   PROTECTIVE COMPLEX WITH SPF 15 FACIAL DAY NORMAL TO DRY SKIN
avobenzone, ensulizole, octinoxate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.02 g  in 1 g
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PEA (UNII: W4X7H8GYFM)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MANNITOL (UNII: 3OWL53L36A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-75 STEARATE (UNII: OT38R0N74H)
METHYLPARABEN (UNII: A2I8C7HI9T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)
CETETH-20 (UNII: I835H2IHHX)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
STEARETH-20 (UNII: L0Q8IK9E08)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURETH-7 (UNII: Z95S6G8201)
DIMETHICONE (UNII: 92RU3N3Y1O)
YEAST (UNII: 3NY3SM6B8U)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
LAURETH-23 (UNII: N72LMW566G)
LAURETH-4 (UNII: 6HQ855798J)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-025-61	1 in 1 BOX
1	NDC: 14783-025-66	50 g in 1 JAR
2	NDC: 14783-025-04	1 in 1 BOX
2	NDC: 14783-025-03	5 g in 1 JAR
3	NDC: 14783-025-01	1 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/14/2012

Labeler - Ventura International Ltd. (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
MF Productions Saumur (France)		266769145	MANUFACTURE