SUN PROTECTION EMULSION FACE BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream 
Temmentec Ag

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 Broad Spectrum 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

Uses

helps prevent sunburn

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 daily after cleansing and toning

- smooth over face & throat

- apply liberally 15 minutes before sun exposure

- children under 6 months of age: Ask a doctor

- reapply at least every 2 hours

- use a water resistant sunscreen if swimming or sweating

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 SPF value 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), 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 Hyalu-ronate, Corallina Officinalis Extract, Sea Water (Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dime- thoxydimethylindanone, Sodium Hydroxide, Porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Palmata 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, Propylparaben.

tube

carton

Sun Protection Emulsion Face

Emulsion Solaire Protectrice Visage

Sunscreen Broad Spectrum SPF 30

La Prairie Switzerland


125 ml 4.2 Fl. Oz.

SUN PROTECTION EMULSION FACE BROAD SPECTRUM SPF 30  LA PRAIRIE GROUP
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68807-321
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 kg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.6 g  in 100 kg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.4 g  in 100 kg
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 kg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 kg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
HEXYLDECANOL (UNII: 151Z7P1317)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARETH-21 (UNII: 53J3F32P58)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CORALLINA OFFICINALIS (UNII: 4004498D06)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
STEARETH-2 (UNII: V56DFE46J5)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SQUALANE (UNII: GW89575KF9)  
CARBOMER 934 (UNII: Z135WT9208)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
DULSE (UNII: 7832HOY4ZQ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
PELVETIA CANALICULATA (UNII: 8U1M44KESN)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
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:68807-321-1178.4 kg in 1 DRUM; Type 0: Not a Combination Product02/14/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/14/2011
Labeler - Temmentec Ag (480586411)
Registrant - Temmentec Ag (480586411)
Establishment
NameAddressID/FEIBusiness Operations
Temmentec Ag480586411manufacture(68807-321)

Revised: 1/2016
Document Id: 7426198b-4344-4cc1-af69-6abc5a20c854
Set id: 91fd9d0f-0f61-41d2-a44e-239e79348ff7
Version: 1
Effective Time: 20160125
 
Temmentec Ag