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.

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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 front image 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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-152-01	1 in 1 KIT	11/14/2012	08/01/2014

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		7.4 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/14/2012	08/01/2014

Part 2 of 4

GENTLE HYDRATING NIGHT JAFRA
face and neck (excluding shaving preparations)

Product Information

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		7.4 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		11/14/2012	08/01/2014

Part 3 of 4

GENTLE CLEANSING JAFRA
face and neck (excluding shaving preparations)

Product Information

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		7.4 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		11/14/2012	08/01/2014

Part 4 of 4

GENTLE SOOTHING TONER JAFRA
face and neck (excluding shaving preparations)

Product Information

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		7.4 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/14/2012	08/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/14/2012	08/01/2014

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Name	Address	ID/FEI	Business Operations
Establishment
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-152, 68828-153)

Revised: 5/2017

Document Id: 1b179285-e5cc-41fb-95b2-844c1e3e057a

Set id: 9dafa8c0-ff70-4886-9f4f-2588011bb2ac

Version: 4

Effective Time: 20170517

Jafra Cosmetics International Inc