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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68828-152
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-152-011 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 7.4 mL
Part 21 TUBE 7.4 mL
Part 31 BOTTLE 7.4 mL
Part 41 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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2.5 g  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.0 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE4.0 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE1.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) 
SQUALANE 
POLYSORBATE 60 
TRIDECYL NEOPENTANOATE 
ALUMINUM STARCH OCTENYLSUCCINATE 
SACCHARIDE ISOMERATE 
POLYACRYLAMIDE (1500 MW) 
C13-14 ISOPARAFFIN 
LAURETH-7 
BUTYLENE GLYCOL 
OAT 
PHENOXYETHANOL 
HEXYLENE GLYCOL 
CAPRYLYL GLYCOL 
POTASSIUM SORBATE 
LICORICE 
CHONDRUS CRISPUS 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
DIMETHICONE 
PUERARIA MONTANA VAR. LOBATA ROOT 
EDETATE TRISODIUM 
PENTYLENE GLYCOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
17.4 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/14/2012
Part 2 of 4
GENTLE HYDRATING NIGHT  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRMEDIUM-CHAIN TRIGLYCERIDES 
INGRALKYL (C12-15) BENZOATE 
INGRGLYCERYL MONOSTEARATE 
INGRPOLYACRYLAMIDE (1500 MW) 
INGRC13-14 ISOPARAFFIN 
INGRLAURETH-7 
INGRLICORICE 
INGRBUTYLENE GLYCOL 
INGROAT 
INGRCETYL ALCOHOL 
INGRPANTHENOL 
INGRDIMETHICONE 
INGRTOCOPHEROL 
INGRGINGER 
INGRLEVOMENOL 
INGRXYLITOL 
INGRDMDM HYDANTOIN 
INGRPEG-4 LAURATE 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGREDETATE TRISODIUM 
INGRTANGERINE PEEL 
INGRPUMMELO 
INGRPELARGONIUM GRAVEOLENS FLOWERING TOP 
INGRORANGE PEEL 
INGRDIPROPYLENE GLYCOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
17.4 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/14/2012
Part 3 of 4
GENTLE CLEANSING  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRETHYLHEXYL STEARATE 
INGRISOPROPYL PALMITATE 
INGRGLYCERIN 
INGRPOLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE 
INGRHYDROGENATED COCO-GLYCERIDES 
INGRSODIUM POLYACRYLATE (8000 MW) 
INGRDMDM HYDANTOIN 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGRALLANTOIN 
INGRPANTHENOL 
INGRTOCOPHEROL 
INGRBUTYLENE GLYCOL 
INGROAT 
INGRLICORICE 
INGREDETATE DISODIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
17.4 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/14/2012
Part 4 of 4
GENTLE SOOTHING TONER  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRPROPYLENE GLYCOL 
INGRSODIUM PYRROLIDONE CARBOXYLATE 
INGRGLYCERIN 
INGRLICORICE 
INGRBUTYLENE GLYCOL 
INGRPANTHENOL 
INGRALLANTOIN 
INGRHAMAMELIS VIRGINIANA TOP 
INGROAT 
INGRPOLYSORBATE 20 
INGRDIAZOLIDINYL UREA 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGREDETATE TRISODIUM 
INGRPUMMELO 
INGRPELARGONIUM GRAVEOLENS FLOWERING TOP 
INGRORANGE PEEL 
INGRDIPROPYLENE GLYCOL 
INGRCITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
17.4 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/14/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/14/2012
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(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