CONTROL DYNAMICS KIT JAFRA- control dynamics tester   
Jafra Cosmetics International Inc

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.

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Control Dynamics Kit

Active Ingredients Purpose

Avobenzone 2.75% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 7.5% 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 product is swallowed, get medical help or
contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs

Warnings

· 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.

Directions
· Apply liberally 15 minutes before sun exposure
· Reapply at least every 2 hours
· Use a water resistant sunscreen if swimming or sweating
· Children under 6 months: Ask a doctor

· Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with broad spectrum SPF of 15 or higher and other sun protection measures
including:
· limit time in the sun, especially from 10 a.m. - 2 p.m.
· wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients


Water/Aqua, Aluminum Starch Octenlsuccinate, Sodium Polyacrylate, Hydrogenated Polydecene, Trideceth-6, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Saccharide Isomerate, Decamethylcyclopentasiloxane, Azadirachta Indica Extract, Tagetus Erecta (African Marigold) Extract, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Butylene Glycol, Panthenol, Chondrus Crispus (carageenan) Extract, Biosaccharide Gum-4, Lysine Thiazolidine Carboxylate, DMDM Hydantoin, Tocopheryl Acetate, Trisodium EDTA, Malic Acid, Hydrolyzed Prunus Amygdalus Dulcis (Sweet Almond) Protein, Butyl Avocadate, Fragrance/Parfum, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polysorbate 20, Ethoxylated Castor Oil, Blue 1/CI42090, Yellow 5/CI 19140, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid,Zingiber Officinale (Ginger) Extract, Bisabolol.

carton back

carton front

Jafra

Control Dynamics

Tester

Contains 4 samples

1 Oil Control Gel Cleanser/1 Oil Control Purifying Toner/1 Mattifying Lotion Broad Spectrum SPF 15/1 Balancing Night Cream

Cont. Net. 55 ml 1,85 Fl Oz (US)

CONTROL DYNAMICS KIT  JAFRA
control dynamics tester kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-121
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68828-121-01 1 in 1 KIT
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 14 TUBE 100 mL
Part 2 7 TUBE 7.4 mL
Part 3 7 BOTTLE 7.4 mL
Part 4 7 TUBE 7.4 mL
Part 1 of 4
MATTIFYING BROAD SPECTRUM SPF 15  JAFRA
avbobenzone, octisalate, octovrylene, oxybenzone lotion
Product Information
Item Code (Source) NDC:68828-122
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.75 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PANTHENOL (UNII: WV9CM0O67Z)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
LYSINE THIAZOLIDINE CARBOXYLATE (UNII: WUG63M652E)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
MALIC ACID (UNII: 817L1N4CKP)  
TEA TREE OIL (UNII: VIF565UC2G)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
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:68828-122-01 7.4 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/22/2013
Part 2 of 4
OIL CONTROL CLEANSER  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR WATER (UNII: 059QF0KO0R)  
INGR SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGR DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
INGR PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
INGR DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
INGR PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
INGR CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGR DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGR SALICYLIC ACID (UNII: O414PZ4LPZ)  
INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
INGR ARGININE (UNII: 94ZLA3W45F)  
INGR POLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGR PANTHENOL (UNII: WV9CM0O67Z)  
INGR ALLANTOIN (UNII: 344S277G0Z)  
INGR SODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGR EDETATE SODIUM (UNII: MP1J8420LU)  
INGR CARBOCYSTEINE LYSINE (UNII: 1D1Y95PXXA)  
INGR LYSINE THIAZOLIDINE CARBOXYLATE (UNII: WUG63M652E)  
INGR TEA TREE OIL (UNII: VIF565UC2G)  
INGR POLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGR D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
INGR PENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGR HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 1 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/22/2013
Part 3 of 4
OIL CONTROL PURIFYING TONER  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR WATER (UNII: 059QF0KO0R)  
INGR POLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGR ARGININE (UNII: 94ZLA3W45F)  
INGR SALICYLIC ACID (UNII: O414PZ4LPZ)  
INGR CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGR DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGR PANTHENOL (UNII: WV9CM0O67Z)  
INGR ALLANTOIN (UNII: 344S277G0Z)  
INGR PENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGR HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
INGR EDETATE TRISODIUM (UNII: 420IP921MB)  
INGR CARBOCYSTEINE LYSINE (UNII: 1D1Y95PXXA)  
INGR LYSINE THIAZOLIDINE CARBOXYLATE (UNII: WUG63M652E)  
INGR MENTHOL (UNII: L7T10EIP3A)  
INGR TEA TREE OIL (UNII: VIF565UC2G)  
INGR DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
INGR D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 1 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/22/2013
Part 4 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 C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
INGR PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
INGR CENTELLA ASIATICA (UNII: 7M867G6T1U)  
INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGR GLYCERIN (UNII: PDC6A3C0OX)  
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 HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
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 1 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/22/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/22/2013
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
Name Address ID/FEI Business Operations
Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-121, 68828-122)

Revised: 2/2013
Document Id: 0e3dd6c0-cce8-4391-9fa9-592b15f563bc
Set id: 42575df5-27eb-46e7-a00b-7df887d1272f
Version: 3
Effective Time: 20130201
 
Jafra Cosmetics International Inc