Pro Set Jafra: Package Insert and Label Information

JAFRA PRO SET- jaft pro
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.

Active ingredients: Octocrylene, Octisalate/Ethylhexyl Salicylate, Homosalate, Butyl Methoxydibenzoyl Methane/Avobenzone.

Sunscreen

Keep out reach of children.

Discontinue use if signs of irritation occur.

Caution: For external use only. Avoid contact with eyes

To use: Apply over face and neck at night after cleansing. Avoid eye area.

Water/Aqua, Butylene Glycol, Sorbitan Laurate, Hydroxyethylcellulose, Acetyl Dipeptide-1, Cetyl Ester, Pentylene Glycol, Cetearyl Alcohol, Coco-glucoside, Algae Extract, Pullulan, Niacinamide, Hydrolyzed Soy Protein, Zea Mays (corn) Kernel Extract, Xanthan Gum, Sodium Hyaluronate, Trehalose, Sodium PCA, Polyquaternium-51, Urea, Glycerin, Avena Sativa (oat) Kernel Extract, Cocos Nucifera (Coconut) oil, Cucumis Sativus (Cucumber) Fruit Extract, Sanalum Album (Sandalwood) Wood Extract, Rose extract, Pyrus Malus (Apple) Fruit Extract, Passiflora Incarnata Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Cananga Odorata Flower Extract, Cucumis Melo Catalupensis Fruit Extract, C20-22 Alkyl Phosphate, C20-22 Alcohols, Caprylic/Capric Triglycerides, Alaria Esculenta Extract, Yeast Amino Acids, Tricalcium Phosphate, Morinda Citrifolia Extract, Carica Papaya Extract, Glycrrhiza Glabra (Licorice) Extract, Pichia Anomala Extract, Tripleurospermum Martima Extract, Microcrystalline Cellulose, Cellulose Gum, Dipotassium Glycyrrhizate, Glycine Soja (Soybean) Oil, Arnica Montana Flower Extract, Tocopherol, DMDM Hydantoin, Hydrogenated Lecithin, Panthenol, Trisodium EDTA, PEG-4 Laurate, Iodopropyl Butylcarbamate, Menthyl Lactate, Benzylidene Dimethoxydimethylindanone, Polyacrylamide, C13-14 Isoparrafin, Laureth-7.

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Face Lift SPF 20

Crema Facial Reafirmante con *FPS 20

4 ml 0.13 Fl Oz (US)

Established Pharmacological Class
Substance Pharmacological Class
Even ToneJafra Pro Face and Neck (excluding shaving preparations)
Night Recovery ConcentrateJafra Pro Face and Neck (excluding shaving preparations)
Dermal Line FillerJafra Pro Face and Neck (excluding shaving preparations)
Eye TransformerJafra Pro Face and Neck (excluding shaving preparations)
Eye TransformerJafra Pro Face and Neck (excluding shaving preparations)
JAFRA PRO SET
jaft pro kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-111
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68828-111-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 4 mL
Part 2 1 TUBE 4 mL
Part 3 1 TUBE 4 mL
Part 4 1 TUBE 4 mL
Part 5 1 TUBE 4 mL
Part 6 1 TUBE 4 mL
Part 1 of 6
JAFRA PRO FACE LIFT SPF 20
octocrylene, octisalate, homosalate, avobenzone cream
Product Information
Item Code (Source) NDC:68828-112
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.28 mL in 4 mL
OCTISALATE (OCTISALATE) OCTISALATE 0.2 mL in 4 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 0.2 mL in 4 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.12 mL in 4 mL
Inactive Ingredients
Ingredient Name Strength
WATER
BUTYLENE GLYCOL
SORBITAN MONOLAURATE
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)
N-ACETYL DIPEPTIDE-1
PENTYLENE GLYCOL
CETOSTEARYL ALCOHOL
COCO GLUCOSIDE
PULLULAN
NIACINAMIDE
TREHALOSE
SODIUM PYRROLIDONE CARBOXYLATE
UREA
GLYCERIN
OAT
CUCUMBER
SANDALWOOD
APPLE
PASSIFLORA INCARNATA FRUIT
APRICOT
RASPBERRY
CANANGA ODORATA FLOWER
MUSKMELON
C20-22 ALKYL PHOSPHATE
MEDIUM-CHAIN TRIGLYCERIDES
ALARIA ESCULENTA
TRICALCIUM PHOSPHATE
MORINDA CITRIFOLIA LEAF
PAPAYA
GLYCYRRHIZA GLABRA LEAF
CELLULOSE, MICROCRYSTALLINE
CARBOXYMETHYLCELLULOSE SODIUM
GLYCYRRHIZINATE DIPOTASSIUM
SOYBEAN OIL
ARNICA MONTANA FLOWER
TOCOPHEROL
DMDM HYDANTOIN
HYDROGENATED SOYBEAN LECITHIN
PANTHENOL
EDETATE TRISODIUM
PEG-4 LAURATE
IODOPROPYNYL BUTYLCARBAMATE
MENTHYL LACTATE, (-)-
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE
C13-14 ISOPARAFFIN
LAURETH-7
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68828-112-01 4 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/30/2012
Part 2 of 6
JAFRA PRO EVEN TONE
Product Information
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
MEDIUM-CHAIN TRIGLYCERIDES
ALKYL (C12-15) BENZOATE
TETRAHEXYLDECYL ASCORBATE
HEXYLRESORCINOL
ETHYL LINOLEATE
NIACINAMIDE
PENTYLENE GLYCOL
TITANIUM DIOXIDE
STANNIC OXIDE
SODIUM POLYACRYLATE (8000 MW)
TRIDECETH-6
CITRIC ACID MONOHYDRATE
PAPAYA
LICORICE
COCONUT OIL
CUCUMBER
SANDALWOOD
PASSIFLORA INCARNATA FLOWER
APRICOT
RASPBERRY
CANANGA ODORATA FLOWER
CANTALOUPE
ALMOND
SOYBEAN OIL
ARNICA MONTANA FLOWER
TOCOPHEROL
DMDM HYDANTOIN
PANTHENOL
GLYCYRRHIZINATE DIPOTASSIUM
EDETATE DISODIUM
PEG-4 LAURATE
IODOPROPYNYL BUTYLCARBAMATE
BUTYLENE GLYCOL
OAT
Packaging
# Item Code Package Description Multilevel Packaging
1 4 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 07/30/2012
Part 3 of 6
JAFRA PRO NIGHT RECOVERY CONCENTRATE
Product Information
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
BUTYLENE GLYCOL
PENTYLENE GLYCOL
ABELMOSCHUS MOSCHATUS SEED
XANTHAN GUM
NIACINAMIDE
HYALURONATE SODIUM
TREHALOSE
SODIUM PYRROLIDONE CARBOXYLATE
UREA
ALMOND
XYLITOL
CESTRUM LATIFOLIUM LEAF
POLYSORBATE 20
PALMITOYL OLIGOPEPTIDE
PEG-8 DIMETHICONE
PULLULAN
PANTHENOL
PAPAYA
LICORICE
CAPRYLYL GLYCOL
COCONUT OIL
CUCUMBER
SANDALWOOD
PASSIFLORA INCARNATA FRUIT
APRICOT
RASPBERRY
CANTALOUPE
SOYBEAN OIL
ARNICA MONTANA FLOWER
TOCOPHEROL
METHYLISOTHIAZOLINONE
OAT
GLYCYRRHIZINATE DIPOTASSIUM
EDETATE TRISODIUM
LACTIC ACID
ISOMALT
Packaging
# Item Code Package Description Multilevel Packaging
1 4 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 07/30/2012
Part 4 of 6
JAFRA PRO DERMAL LINE FILLER
Product Information
Ingredients
Ingredient Name Quantity
WATER
DIMETHICONE
COPOVIDONE K25-31
HYPROMELLOSES
GLYCERIN
SODIUM POLYACRYLATE (8000 MW)
CYCLOMETHICONE 5
TRIDECETH-6
PEG/PPG-18/18 DIMETHICONE
SILICON DIOXIDE
PENTYLENE GLYCOL
BUTYLENE GLYCOL
POLYSORBATE 20
PALMITOYL OLIGOPEPTIDE
RYE
MEDIUM-CHAIN TRIGLYCERIDES
ACMELLA OLERACEA FLOWER
HYALURONATE SODIUM
TREHALOSE
SODIUM PYRROLIDONE CARBOXYLATE
ALMOND
PAPAYA
LICORICE
ETHYLHEXYL PALMITATE
DMDM HYDANTOIN
CUCUMBER
SANDALWOOD
PASSIFLORA INCARNATA FRUIT
APRICOT
RASPBERRY
CANANGA ODORATA FLOWER
CANTALOUPE
PANTHENOL
NIACINAMIDE
SOYBEAN OIL
RASPBERRY
ARNICA MONTANA FLOWER
TOCOPHEROL
EDETATE TRISODIUM
IODOPROPYNYL BUTYLCARBAMATE
OAT
GLYCYRRHIZINATE DIPOTASSIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 4 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 07/30/2012
Part 5 of 6
JAFRA PRO EYE TRANSFORMER
Product Information
Ingredients
Ingredient Name Quantity
WATER
MEDIUM-CHAIN TRIGLYCERIDES
SQUALANE
POLYSORBATE 60
BUTYLENE GLYCOL
PANTHENOL
ESCIN
GLYCERIN
RUSCUS ACULEATUS ROOT
AMMONIUM GLYCYRRHIZATE
CENTELLA ASIATICA
CALENDULA OFFICINALIS FLOWER
PENTYLENE GLYCOL
ACMELLA OLERACEA FLOWER
SACCHARIDE ISOMERATE
POLYACRYLAMIDE (1500 MW)
C13-14 ISOPARAFFIN
LAURETH-7
LAMINARIA OCHROLEUCA
ALMOND
STEARETH-20
PALMITOYL TETRAPEPTIDE-7
PALMITOYL OLIGOPEPTIDE
CHRYSIN
LAMINARIA HYPERBOREA
SOYBEAN OIL
ARNICA MONTANA FLOWER
TOCOPHEROL
TITANIUM DIOXIDE
STANNIC OXIDE
GLYCYRRHIZINATE DIPOTASSIUM
ALLANTOIN
ALPHA-TOCOPHEROL ACETATE
COCONUT OIL
CUCUMBER
SANDALWOOD
PASSIFLORA INCARNATA FRUIT
apricot
RASPBERRY
CANTALOUPE
CANANGA ODORATA FLOWER
PEG-4 LAURATE
IODOPROPYNYL BUTYLCARBAMATE
OAT
PAPAYA
LICORICE
EDETATE TRISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 4 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 07/30/2012
Part 6 of 6
JAFRA PRO EYE TRANSFORMER
Product Information
Ingredients
Ingredient Name Quantity
WATER
MEDIUM-CHAIN TRIGLYCERIDES
SQUALANE
POLYSORBATE 60
BUTYLENE GLYCOL
PANTHENOL
ESCIN
GLYCERIN
RUSCUS ACULEATUS ROOT
AMMONIUM GLYCYRRHIZATE
CENTELLA ASIATICA
CALENDULA OFFICINALIS FLOWER
PENTYLENE GLYCOL
ACMELLA OLERACEA FLOWER
SACCHARIDE ISOMERATE
C13-14 ISOPARAFFIN
LAURETH-7
ALMOND
STEARETH-20
CHRYSIN
N-HYDROXYSUCCINIMIDE
LAMINARIA HYPERBOREA
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)
SOYBEAN OIL
ARNICA MONTANA FLOWER
TOCOPHEROL
TITANIUM DIOXIDE
STANNIC OXIDE
DMDM HYDANTOIN
DISODIUM GLYCYRRHIZATE
ALLANTOIN
ALPHA-TOCOPHEROL ACETATE
COCONUT OIL
CUCUMBER
SANDALWOOD
PASSIFLORA INCARNATA FRUIT
APRICOT
RASPBERRY
CANANGA ODORATA FLOWER
CANTALOUPE
PEG-4 LAURATE
IODOPROPYNYL BUTYLCARBAMATE
OAT
PAPAYA
LICORICE
EDETATE TRISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 4 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 07/30/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/30/2012
Labeler — Jafra Cosmetics International Inc (041676479)
Registrant — Jafra Cosmetics International Inc (041676479)
Establishment
Name Address ID/FEI Operations
Jafra Manufacturing, S.A. de C.V. 814732061 manufacture (68828-111), manufacture (68828-112)

Revised: 08/2012 Jafra Cosmetics International Inc

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