CALMING DYNAMICS KIT JAFRA- calming testers   
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.

----------

Calming Dynamics Testers

Active Ingredients Purpose

Avobenzone 2.5 % Sunscreen

Octinoxate 7.0 % Sunscreen

Octisalate 4.0 % Sunscreen

Oxybenzone 1.0% Sunscreen

Uses

Helps prevent sunnburn

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.

Warnings

For external use only

Do not use on damaged or broken skin

When using this project keep out of eyes. Rinse with water to remove.

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 your risk of skin cancer and early skin aging. To decrease this risk. regularly 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. - 2 p.m.

wear long-sleeve shirts, pants, hats and sunglasses

Inactive ingredients: Water/aqua, C12-15 Alkyl Benzoate, Hydroxyethyl Acrylate/ Sodium Acryloyl dimethyltaurate Copolymer, Squalane, Polysorbate 60, Tridecyl Neopentanoate, Aluminum starch Octenylsuccinate, Saccharide Isomerate, Polyacrylamide, C13-14 Isoparrafin, Laureth-7, Butylene Glycol, Avena Sativa (Oat) Kernel Extract, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Hemidesmus Indicus Extract, Phyllanthus Emblica Extract, Glycrrhiza Glabra (licorice) Extract, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Panthenol, Tocopheryl Acetate, Dimethicone, Pueraria Lobata Root Extract, Trisodium EDTA, Pentylene Glycol, Propamidobenzoic acid.

image of carton frontimage of carton back


Jafra

Calming Dynamics

Tester

Contains:4 samples

1 Gentle Hydrating Night Cream/ 1 Gentle Cleansing Lotion/ 1 Gentle Soothing Toner/ 1 Gentle Hydrating Day Cream Broad Spectrum SPF 15

Cont. Net. 60 ml 2 Fl Oz (US)

CALMING DYNAMICS KIT  JAFRA
calming testers kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-152
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68828-152-01 1 in 1 KIT
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 7.4 mL
Part 2 1 TUBE 7.4 mL
Part 3 1 BOTTLE 7.4 mL
Part 4 1 BOTTLE 7.4 mL
Part 1 of 4
GENTLE HYDRATING DAY BROAD SPECTRUM SPF 15  JAFRA
avobenzone, octinoxate, octisalate, oxybenzone cream
Product Information
Item Code (Source) NDC:68828-153
Route of Administration TOPICAL DEA Schedule     
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 1.0 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
SQUALANE (UNII: GW89575KF9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OAT (UNII: Z6J799EAJK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
LICORICE (UNII: 61ZBX54883)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 7.4 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/14/2012
Part 2 of 4
GENTLE HYDRATING NIGHT  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR WATER (UNII: 059QF0KO0R)  
INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGR POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
INGR C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
INGR LAURETH-7 (UNII: Z95S6G8201)  
INGR LICORICE (UNII: 61ZBX54883)  
INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGR OAT (UNII: Z6J799EAJK)  
INGR CETYL ALCOHOL (UNII: 936JST6JCN)  
INGR PANTHENOL (UNII: WV9CM0O67Z)  
INGR DIMETHICONE (UNII: 92RU3N3Y1O)  
INGR TOCOPHEROL (UNII: R0ZB2556P8)  
INGR GINGER (UNII: C5529G5JPQ)  
INGR LEVOMENOL (UNII: 24WE03BX2T)  
INGR XYLITOL (UNII: VCQ006KQ1E)  
INGR DMDM HYDANTOIN (UNII: BYR0546TOW)  
INGR PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGR EDETATE TRISODIUM (UNII: 420IP921MB)  
INGR TANGERINE PEEL (UNII: JU3D414057)  
INGR PUMMELO (UNII: ET1TN5W71X)  
INGR PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
INGR ORANGE PEEL (UNII: TI9T76XD44)  
INGR DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 7.4 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 11/14/2012
Part 3 of 4
GENTLE CLEANSING  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR WATER (UNII: 059QF0KO0R)  
INGR ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
INGR ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
INGR GLYCERIN (UNII: PDC6A3C0OX)  
INGR POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
INGR HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
INGR SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
INGR DMDM HYDANTOIN (UNII: BYR0546TOW)  
INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGR ALLANTOIN (UNII: 344S277G0Z)  
INGR PANTHENOL (UNII: WV9CM0O67Z)  
INGR TOCOPHEROL (UNII: R0ZB2556P8)  
INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGR OAT (UNII: Z6J799EAJK)  
INGR LICORICE (UNII: 61ZBX54883)  
INGR EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 7.4 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 11/14/2012
Part 4 of 4
GENTLE SOOTHING TONER  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR WATER (UNII: 059QF0KO0R)  
INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGR GLYCERIN (UNII: PDC6A3C0OX)  
INGR LICORICE (UNII: 61ZBX54883)  
INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGR PANTHENOL (UNII: WV9CM0O67Z)  
INGR ALLANTOIN (UNII: 344S277G0Z)  
INGR HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
INGR OAT (UNII: Z6J799EAJK)  
INGR POLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGR DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGR EDETATE TRISODIUM (UNII: 420IP921MB)  
INGR PUMMELO (UNII: ET1TN5W71X)  
INGR PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
INGR ORANGE PEEL (UNII: TI9T76XD44)  
INGR DIPROPYLENE GLYCOL (UNII: E107L85C40)  
INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 7.4 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/14/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/14/2012
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(68828-152, 68828-153)

Revised: 2/2013
Document Id: 61349046-fe58-4069-b4ab-67fab71de0af
Set id: 9dafa8c0-ff70-4886-9f4f-2588011bb2ac
Version: 2
Effective Time: 20130204
 
Jafra Cosmetics International Inc