BALANCING DYNAMICS KIT JAFRA- balancing dynamics kit

Balancing Dynamics Kit by

Drug Labeling and Warnings

Balancing Dynamics Kit by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Avobenzone 2.5% Suncreen

Octinoxate 7% Sunscreen

Octisalate 4% Sunscreen

Oxybenzone 2% Sunscreen

Uses

helps prevent sunburn

If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask a doctor if rash occurs.

Directions

- Apply liberally 15 minutes before sun exposure

- Use a water resistant sunscreen, if swimming or sweating

- Reapply at least every 2 hours

- Children under 6 months: ask a doctor

Sun Protection measures.

Spending time in the sun increases risk of skin cancer and early skin aging. To decrease this risk, regulalrly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- limit time in the sun, especially from 10 a.m. to 2 p.m.

- Wear long sleeve shirts, pants, hats, and sunglasses

Water/Aqua, Tribehenin PEG-20 Esters, Dimethicone, Dimethicone Crosspolymer, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Centella Asiatica Extract, Withania Somniferia Extract, Butylene Glycol, Glyceryl Stearate, Bis-Diglyceryl Polyacyladipate-2, Iris Florentina Root Extract, Retinyl Palmitate, Zinc Sulfate, Alcohol, Propylene Glycol, Biosaccharide Gum-1, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Xylitol, Xylitan, Xylitiyl Polyglucoside, Glycerin, Butyrospermum Parkii (Shea Butter) Fruit, Acrylates Copolymer, Cyclomethicone, Laminaria Saccharina Extract, Silanediol Salicylate, Chondrus Crispus (Carrageenan) Extract, Biosaccharide Gum-4, Triethanolamine, Panthenol, Tocopheryl Acetate, Carbomer, Xanthan Gum, Fragrance/Parfum, Trisodium EDTA, Yellow 6/CI 15985, Red 33/CI 17200, Pentylene Glycol, Propamidobenzoic Acid, Zingiber Officinale (Ginger) Extract, Bisabolol.

PRINCIPAL DISPLAY PANEL

Jafra

Balancing Dynamics

Tester

Contains: 4 Samples

1 Balancing Night Cream/ 1 Balancing Cleansing Gel/ 1 Balancing toner/ 1 Balancing lotion Broad Spectrum SPF 15

Cont. Net. 60 ml 2 fl oz

INGREDIENTS AND APPEARANCE

BALANCING DYNAMICS KIT  JAFRA
balancing dynamics kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-154

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-154-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	11/16/2012

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	30 BOTTLE	7.39 mL
Part 2	1 TUBE	7.39 mL
Part 3	1 TUBE	7.3 mL
Part 4	1 TUBE	7.39 mL

Part 1 of 4

BALANCING BROAD SPECTRUM  JAFRA
avobenzone, octinoxate, octisalate, oxybezone lotion

Product Information
Item Code (Source)	NDC: 68828-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.0 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
DIMETHICONE (UNII: 92RU3N3Y1O)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ZINC SULFATE (UNII: 89DS0H96TB)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XYLITOL (UNII: VCQ006KQ1E)
XYLITAN (UNII: 5KQL0CX6R6)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
CYCLOMETHICONE (UNII: NMQ347994Z)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
TROLAMINE (UNII: 9O3K93S3TK)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 934 (UNII: Z135WT9208)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE TRISODIUM (UNII: 420IP921MB)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
GINGER (UNII: C5529G5JPQ)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-157-01	.25 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/16/2012

Part 2 of 4

BALANCING NIGHT CREAM  JAFRA
face and neck (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	CENTELLA ASIATICA (UNII: 7M867G6T1U)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
INGR	XYLITOL (UNII: VCQ006KQ1E)
INGR	XYLITAN (UNII: 5KQL0CX6R6)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	BENZOPHENONE-9 (UNII: 7925W14T4L)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)
INGR	MANGANESE CARBONATE (UNII: 9ZV57512ZM)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	GINGER (UNII: C5529G5JPQ)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.3 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		11/19/2012

Part 3 of 4

BALANCING CLEANSING GEL  JAFRA
face and neck (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	POTASSIUM COCOATE (UNII: F8U72V8ZXP)
INGR	SORBITOL (UNII: 506T60A25R)
INGR	GLYCERETH-26 (UNII: NNE56F2N14)
INGR	GLYCOL STEARATE (UNII: 0324G66D0E)
INGR	PROPYLENE GLYCOL ALGINATE (UNII: 26CD3J2R0C)
INGR	CENTELLA ASIATICA (UNII: 7M867G6T1U)
INGR	WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
INGR	IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	ZINC SULFATE (UNII: 89DS0H96TB)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.39 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		11/19/2012

Part 4 of 4

BALANCING TONER  JAFRA
face and neck (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
INGR	CENTELLA ASIATICA (UNII: 7M867G6T1U)
INGR	WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	ZINC SULFATE (UNII: 89DS0H96TB)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	FD&C RED NO. 4 (UNII: X3W0AM1JLX)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.39 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		11/20/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/16/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-154, 68828-157)