SUN PROTECTION EMULSION FACE  LA PRAIRIE- avobenzone, homosalate, octisalate, octocrylene, oxybenzone  cream 
Juvena GMBH

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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Sun Protection Emulsion Face SPF 30

Active Ingredients            Purpose

Avobenzone 3.0%            sunscreen

Homosalate   10.0%         sunscreen

Octisalate 2.6%                sunscreen

octocrylene 2.4%              sunscreen

Oxybenzone 5.0%            sunscreen


- Helps prevent sunburn

- for skin that burns easily

-provides moderate protection against sunburn

-higher SPF gives more sunburn protection

Keep out of reach of children.

Do not use on infants under 6 months of age.

Stop use and ask a doctor if rash or irritation develops and lasts.

when using this product keep out of eyes.

rinse with water to remove.

Apply daily after cleansing and toning .

Smooth over face and throat.

Apply evenly before sun exposure.

Reapply as needed or after towel drying, swimming or perspiring.

Water (Aqua), Caprylyl Methicone, Hexyldecanol, Dimethicone, Polyglyceryl-3 Methylglucose Distearate, Undercrylene Dimethicone, Aluminum Starch Octenylsuccinate, Steareth-21, Octyldodecyl Olivate, Cetyl Alcohol, Silica, Glycerin, Glycoproteins, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Sodium Hyaluronate, Corallina Officinalis Extract, Sea Water ( Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dimethoxydimethylindanone, sodium hydroxide, porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Pakmata Extract, Tocopheryl Acetate, Diethylhexyl Syringyldenemalonate, Pelvetia Canaliculata Extract, Polysorbate 60, Lecithin, Caprylic/ Capric Triglyceride, Sodium Lactate, Caprylyl Glycol, Alcohol, Benzyl Alcohol, Fragrance ( parfum), Phenoxyethanol, Chlorphenesin, Sodium Benzoate, Methylparaben, Ethylparaben, Propyparaben





image of back label

Sun protection emulsion face SPF 30


125mL/ 4.2 FL. OZ.


image of front label

SUN PROTECTION EMULSION FACE   LA PRAIRIE
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59614-221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mL  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) Octisalate 2.5 mL  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.4 mL  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Hexyldecanol (UNII: 151Z7P1317)  
Dimethicone (UNII: 92RU3N3Y1O)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
STEARETH-21 (UNII: 53J3F32P58)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
STEARETH-2 (UNII: V56DFE46J5)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
squalane (UNII: GW89575KF9)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
alcohol (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59614-221-110.088 mL in 1 DRUM
2NDC:59614-221-021 in 1 BOX
2NDC:59614-221-01125 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/14/2011
Labeler - Juvena GMBH (315053785)
Registrant - Juvena GMBH (315053785)
Establishment
NameAddressID/FEIBusiness Operations
Temmentec Ag480586411manufacture

Revised: 2/2011
Document Id: 10ada59f-faaf-47e7-b15a-b96e5118ebe1
Set id: 688e7583-7e08-44f0-9af5-cec94678da25
Version: 2
Effective Time: 20110214
 
Juvena GMBH