JAFRA PRO- avobenzone, homosalate, octisalate, octocrylene   
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.

----------

Jafra Pro set

Avobenzone 3% Sunscreen

Homosalate 5% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 7% Sunscreen

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 swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs

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

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 Value of 15 or higher and other sunscreen 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, Butylene Glycol, Sorbitan Laurate, Hydroxyethylcellulose, Acetyl Dipeptide-1, Cetyl Ester, Pentylene Glycol, Cetearyl Alcohol, Coco-glucoside, Microcrystalline Cellulose, Cellulose Gum, C20-22 Alkyl Phosphate, C20-22 Alcohols, 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, Santalum 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 Cantalupensis Fruit Extract, Caprylic/Capric Triglyceride, Alaria Esculenta Extract, Yeast Amino Acids, Tricalcium Phosphate, Morinda Citrifolia Extract, Carica Papaya Extract, Glycyrrhiza Glabra (Licorice) Extract, Pichia Anomala Extract, Tripleurospermum Maritima Extract, Dipotassium Glycyrrhizate, Glycine Soja (Soybean) Oil, Arnica Montana Flower Extract, Tocopherol, DMDM Hydantoin, Hydrogenated Lecithin, Panthenol, Trisodium EDTA, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Menthyl Lactate, Benzylidene Dimethoxydimethylindanone

image of carton backimage carton frontimage of insert pt 1image of insert pt 2

Jafra Pro

Multidimensional technology helps mimic the appearance of young skin

Contains six tubes at 4 ml 0.13 Fl Oz (US) each

JAFRA PRO 
avobenzone, homosalate, octisalate, octocrylene kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68828-111
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-111-011 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 4 mL
Part 21 TUBE 4 mL
Part 31 TUBE 4 mL
Part 41 TUBE 4 mL
Part 51 TUBE 4 mL
Part 61 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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE0.28 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE0.2 g  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE0.2 g  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE0.12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
SORBITAN MONOLAURATE 
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) 
N-ACETYL DIPEPTIDE-1 
PENTYLENE GLYCOL 
CETOSTEARYL ALCOHOL 
COCO GLUCOSIDE 
CELLULOSE, MICROCRYSTALLINE 
C20-22 ALKYL PHOSPHATE 
C20-22 ALCOHOLS 
PULLULAN 
NIACINAMIDE 
CORN 
XANTHAN GUM 
HYALURONATE SODIUM 
TREHALOSE 
SODIUM PYRROLIDONE CARBOXYLATE 
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) 
UREA 
GLYCERIN 
OAT 
CUCUMBER 
SANDALWOOD 
APPLE 
PASSIFLORA INCARNATA FRUIT 
APRICOT 
RASPBERRY 
CANANGA ODORATA FLOWER 
CANTALOUPE 
MEDIUM-CHAIN TRIGLYCERIDES 
ALARIA ESCULENTA 
TRICALCIUM PHOSPHATE 
MORINDA CITRIFOLIA LEAF 
PAPAYA 
LICORICE 
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 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-112-014 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/30/2012
Part 2 of 6
JAFRA PRO  EVEN TONE
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRGLYCERIN 
INGRMEDIUM-CHAIN TRIGLYCERIDES 
INGRALKYL (C12-15) BENZOATE 
INGRTETRAHEXYLDECYL ASCORBATE 
INGRHEXYLRESORCINOL 
INGRETHYL LINOLEATE 
INGRNIACINAMIDE 
INGRPENTYLENE GLYCOL 
INGRTITANIUM DIOXIDE 
INGRSTANNIC OXIDE 
INGRSODIUM POLYACRYLATE (8000 MW) 
INGRTRIDECETH-6 
INGRCITRIC ACID MONOHYDRATE 
INGRPAPAYA 
INGRLICORICE 
INGRCOCONUT OIL 
INGRCUCUMBER 
INGRSANDALWOOD 
INGRPASSIFLORA INCARNATA FLOWER 
INGRAPRICOT 
INGRRASPBERRY 
INGRCANANGA ODORATA FLOWER 
INGRCANTALOUPE 
INGRALMOND 
INGRSOYBEAN OIL 
INGRARNICA MONTANA FLOWER 
INGRTOCOPHEROL 
INGRDMDM HYDANTOIN 
INGRPANTHENOL 
INGRGLYCYRRHIZINATE DIPOTASSIUM 
INGREDETATE DISODIUM 
INGRPEG-4 LAURATE 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGRBUTYLENE GLYCOL 
INGROAT 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/30/2012
Part 3 of 6
JAFRA PRO  NIGHT RECOVERY CONCENTRATE
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRGLYCERIN 
INGRBUTYLENE GLYCOL 
INGRPENTYLENE GLYCOL 
INGRABELMOSCHUS MOSCHATUS SEED 
INGRXANTHAN GUM 
INGRNIACINAMIDE 
INGRHYALURONATE SODIUM 
INGRTREHALOSE 
INGRSODIUM PYRROLIDONE CARBOXYLATE 
INGRUREA 
INGRALMOND 
INGRXYLITOL 
INGRCESTRUM LATIFOLIUM LEAF 
INGRPOLYSORBATE 20 
INGRPALMITOYL OLIGOPEPTIDE 
INGRPEG-8 DIMETHICONE 
INGRPULLULAN 
INGRPANTHENOL 
INGRPAPAYA 
INGRLICORICE 
INGRCAPRYLYL GLYCOL 
INGRCOCONUT OIL 
INGRCUCUMBER 
INGRSANDALWOOD 
INGRPASSIFLORA INCARNATA FRUIT 
INGRAPRICOT 
INGRRASPBERRY 
INGRCANTALOUPE 
INGRSOYBEAN OIL 
INGRARNICA MONTANA FLOWER 
INGRTOCOPHEROL 
INGRMETHYLISOTHIAZOLINONE 
INGROAT 
INGRGLYCYRRHIZINATE DIPOTASSIUM 
INGREDETATE TRISODIUM 
INGRLACTIC ACID 
INGRISOMALT 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/30/2012
Part 4 of 6
JAFRA PRO  DERMAL LINE FILLER
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRDIMETHICONE 
INGRCOPOVIDONE K25-31 
INGRHYPROMELLOSES 
INGRGLYCERIN 
INGRSODIUM POLYACRYLATE (8000 MW) 
INGRCYCLOMETHICONE 5 
INGRTRIDECETH-6 
INGRPEG/PPG-18/18 DIMETHICONE 
INGRSILICON DIOXIDE 
INGRPENTYLENE GLYCOL 
INGRBUTYLENE GLYCOL 
INGRPOLYSORBATE 20 
INGRPALMITOYL OLIGOPEPTIDE 
INGRRYE 
INGRMEDIUM-CHAIN TRIGLYCERIDES 
INGRACMELLA OLERACEA FLOWER 
INGRHYALURONATE SODIUM 
INGRTREHALOSE 
INGRSODIUM PYRROLIDONE CARBOXYLATE 
INGRALMOND 
INGRPAPAYA 
INGRLICORICE 
INGRETHYLHEXYL PALMITATE 
INGRDMDM HYDANTOIN 
INGRCUCUMBER 
INGRSANDALWOOD 
INGRPASSIFLORA INCARNATA FRUIT 
INGRAPRICOT 
INGRRASPBERRY 
INGRCANANGA ODORATA FLOWER 
INGRCANTALOUPE 
INGRPANTHENOL 
INGRNIACINAMIDE 
INGRSOYBEAN OIL 
INGRRASPBERRY 
INGRARNICA MONTANA FLOWER 
INGRTOCOPHEROL 
INGREDETATE TRISODIUM 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGROAT 
INGRGLYCYRRHIZINATE DIPOTASSIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/30/2012
Part 5 of 6
JAFRA PRO  EYE TRANSFORMER
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRMEDIUM-CHAIN TRIGLYCERIDES 
INGRSQUALANE 
INGRPOLYSORBATE 60 
INGRBUTYLENE GLYCOL 
INGRPANTHENOL 
INGRESCIN 
INGRGLYCERIN 
INGRRUSCUS ACULEATUS ROOT 
INGRAMMONIUM GLYCYRRHIZATE 
INGRCENTELLA ASIATICA 
INGRCALENDULA OFFICINALIS FLOWER 
INGRPENTYLENE GLYCOL 
INGRACMELLA OLERACEA FLOWER 
INGRSACCHARIDE ISOMERATE 
INGRPOLYACRYLAMIDE (1500 MW) 
INGRC13-14 ISOPARAFFIN 
INGRLAURETH-7 
INGRLAMINARIA OCHROLEUCA 
INGRALMOND 
INGRSTEARETH-20 
INGRPALMITOYL TETRAPEPTIDE-7 
INGRPALMITOYL OLIGOPEPTIDE 
INGRCHRYSIN 
INGRLAMINARIA HYPERBOREA 
INGRSOYBEAN OIL 
INGRARNICA MONTANA FLOWER 
INGRTOCOPHEROL 
INGRTITANIUM DIOXIDE 
INGRSTANNIC OXIDE 
INGRGLYCYRRHIZINATE DIPOTASSIUM 
INGRALLANTOIN 
INGRALPHA-TOCOPHEROL ACETATE 
INGRCOCONUT OIL 
INGRCUCUMBER 
INGRSANDALWOOD 
INGRPASSIFLORA INCARNATA FRUIT 
INGRapricot 
INGRRASPBERRY 
INGRCANTALOUPE 
INGRCANANGA ODORATA FLOWER 
INGRPEG-4 LAURATE 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGROAT 
INGRPAPAYA 
INGRLICORICE 
INGREDETATE TRISODIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/30/2012
Part 6 of 6
JAFRA PRO  EYE TRANSFORMER
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRMEDIUM-CHAIN TRIGLYCERIDES 
INGRSQUALANE 
INGRPOLYSORBATE 60 
INGRBUTYLENE GLYCOL 
INGRPANTHENOL 
INGRESCIN 
INGRGLYCERIN 
INGRRUSCUS ACULEATUS ROOT 
INGRAMMONIUM GLYCYRRHIZATE 
INGRCENTELLA ASIATICA 
INGRCALENDULA OFFICINALIS FLOWER 
INGRPENTYLENE GLYCOL 
INGRACMELLA OLERACEA FLOWER 
INGRSACCHARIDE ISOMERATE 
INGRC13-14 ISOPARAFFIN 
INGRLAURETH-7 
INGRALMOND 
INGRSTEARETH-20 
INGRCHRYSIN 
INGRN-HYDROXYSUCCINIMIDE 
INGRLAMINARIA HYPERBOREA 
INGRPOLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) 
INGRSOYBEAN OIL 
INGRARNICA MONTANA FLOWER 
INGRTOCOPHEROL 
INGRTITANIUM DIOXIDE 
INGRSTANNIC OXIDE 
INGRDMDM HYDANTOIN 
INGRDISODIUM GLYCYRRHIZATE 
INGRALLANTOIN 
INGRALPHA-TOCOPHEROL ACETATE 
INGRCOCONUT OIL 
INGRCUCUMBER 
INGRSANDALWOOD 
INGRPASSIFLORA INCARNATA FRUIT 
INGRAPRICOT 
INGRRASPBERRY 
INGRCANANGA ODORATA FLOWER 
INGRCANTALOUPE 
INGRPEG-4 LAURATE 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGROAT 
INGRPAPAYA 
INGRLICORICE 
INGREDETATE TRISODIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/30/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/30/2012
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-111, 68828-112)

Revised: 4/2013
Document Id: ad22c152-00ea-4fb8-bd10-e749369ed9a5
Set id: b771858c-0dab-4a78-9e17-b75d345a8e9e
Version: 7
Effective Time: 20130404
 
Jafra Cosmetics International Inc