Your browser does not support JavaScript! CONTROL DYNAMICS KIT JAFRA (CONTROL DYNAMICS TESTER) KIT [JAFRA COSMETICS INTERNATIONAL INC]
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CONTROL DYNAMICS KIT JAFRA (control dynamics tester) kit
[Jafra Cosmetics International Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68828-121
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-121-011 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 114 TUBE 100 mL
Part 27 TUBE 7.4 mL
Part 37 BOTTLE 7.4 mL
Part 47 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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2.75 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE7.5 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALUMINUM STARCH OCTENYLSUCCINATE 
SODIUM POLYACRYLATE (8000 MW) 
HYDROGENATED POLYDECENE (550 MW) 
TRIDECETH-6 
PHENOXYETHANOL 
HEXYLENE GLYCOL 
CAPRYLYL GLYCOL 
POTASSIUM SORBATE 
SACCHARIDE ISOMERATE 
CYCLOMETHICONE 5 
CALENDULA OFFICINALIS FLOWER 
BUTYLENE GLYCOL 
PANTHENOL 
CHONDRUS CRISPUS 
LYSINE THIAZOLIDINE CARBOXYLATE 
DMDM HYDANTOIN 
.ALPHA.-TOCOPHEROL ACETATE 
EDETATE TRISODIUM 
MALIC ACID 
TEA TREE OIL 
POLYSORBATE 20 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
PENTYLENE GLYCOL 
HYDROXYPHENYL PROPAMIDOBENZOIC ACID 
GINGER 
LEVOMENOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-122-017.4 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/22/2013
Part 2 of 4
OIL CONTROL CLEANSER  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRSODIUM LAURETH SULFATE 
INGRCOCAMIDOPROPYL BETAINE 
INGRDISODIUM LAURETH SULFOSUCCINATE 
INGRPEG-150 PENTAERYTHRITYL TETRASTEARATE 
INGRDECYL GLUCOSIDE 
INGRPEG-7 GLYCERYL COCOATE 
INGRCALENDULA OFFICINALIS FLOWER 
INGRBUTYLENE GLYCOL 
INGRPROPYLENE GLYCOL 
INGRDIAZOLIDINYL UREA 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGRSALICYLIC ACID 
INGRDIETHYLENE GLYCOL MONOETHYL ETHER 
INGRARGININE 
INGRPOLYSORBATE 20 
INGRPANTHENOL 
INGRALLANTOIN 
INGRSODIUM CHLORIDE 
INGREDETATE SODIUM 
INGRCARBOCYSTEINE LYSINE 
INGRLYSINE THIAZOLIDINE CARBOXYLATE 
INGRTEA TREE OIL 
INGRPOLYSORBATE 20 
INGRD&C GREEN NO. 5 
INGRPENTYLENE GLYCOL 
INGRHYDROXYPHENYL PROPAMIDOBENZOIC ACID 
INGRFD&C YELLOW NO. 5 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/22/2013
Part 3 of 4
OIL CONTROL PURIFYING TONER  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRPOLYSORBATE 20 
INGRSODIUM PYRROLIDONE CARBOXYLATE 
INGRARGININE 
INGRSALICYLIC ACID 
INGRCALENDULA OFFICINALIS FLOWER 
INGRBUTYLENE GLYCOL 
INGRPROPYLENE GLYCOL 
INGRDIAZOLIDINYL UREA 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGRPANTHENOL 
INGRALLANTOIN 
INGRPENTYLENE GLYCOL 
INGRHYDROXYPHENYL PROPAMIDOBENZOIC ACID 
INGREDETATE TRISODIUM 
INGRCARBOCYSTEINE LYSINE 
INGRLYSINE THIAZOLIDINE CARBOXYLATE 
INGRMENTHOL 
INGRTEA TREE OIL 
INGRDENATONIUM BENZOATE 
INGRD&C GREEN NO. 5 
INGRFD&C YELLOW NO. 5 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/22/2013
Part 4 of 4
BALANCING NIGHT CREAM  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRC12-15 ALKYL BENZOATE 
INGRPHYLLANTHUS EMBLICA FRUIT 
INGRCENTELLA ASIATICA 
INGRBUTYLENE GLYCOL 
INGRGLYCERIN 
INGRGLYCERIN 
INGRSODIUM POLYACRYLATE (8000 MW) 
INGRXYLITOL 
INGRXYLITAN 
INGRCYCLOMETHICONE 5 
INGRPROPYLENE GLYCOL 
INGRDIAZOLIDINYL UREA 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGRBENZOPHENONE-9 
INGRPANTHENOL 
INGR.ALPHA.-TOCOPHEROL ACETATE 
INGREDETATE TRISODIUM 
INGRMANGANESE CARBONATE 
INGRHYDROXYPHENYL PROPAMIDOBENZOIC ACID 
INGRGINGER 
INGRLEVOMENOL 
INGRFD&C BLUE NO. 1 
INGRD&C RED NO. 33 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/22/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/22/2013
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-121, 68828-122)

Revised: 2/2013
 
Jafra Cosmetics International Inc

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