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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-121-01	1 in 1 KIT	01/22/2013	08/01/2014

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-122-01	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 final	part352	01/22/2013	08/01/2014

Part 2 of 4

OIL CONTROL CLEANSER JAFRA
face and neck (excluding shaving preparations)

Product Information

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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	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	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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		1 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		01/22/2013	08/01/2014

Part 3 of 4

OIL CONTROL PURIFYING TONER JAFRA
face and neck (excluding shaving preparations)

Product Information

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		1 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		01/22/2013	08/01/2014

Part 4 of 4

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

Product Information

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
INGR	CENTELLA ASIATICA (UNII: 7M867G6T1U)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		1 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		01/22/2013	08/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/22/2013	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(68828-121, 68828-122)

Revised: 5/2017

Document Id: c37afa74-f826-47ca-80ea-eeff9e0bd44c

Set id: 42575df5-27eb-46e7-a00b-7df887d1272f

Version: 4

Effective Time: 20170511

Jafra Cosmetics International Inc