ANTI-AGING CONCEALER FACE EYES SUNSCREEN SPF 20 SHADE 40 - octinoxate, octisalate and oxybenzone cream 
La Prairie, 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.

----------

Drug Facts


Active Ingredients

Octinoxate    7.5%
Octisalate     5.0%
Oxybenzone 2.0%

Purpose

Sunscreen

Uses:

  • helps prevent sunburn

Warnings

  • Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
    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.

Stop use and ask a doctor if

  • rash occurs

Keep out of reach of children.

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

Directions:

  • apply daily after cleansing and toning
  • with applicator, smooth a small amount over the entire eye area and then blend with fingertips
  • 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

Inactive Ingredients:

  • Water (Aqua), Cyclopentasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Hydrogenated Polyisobutene, Cyclohexasiloxane, BIS-PEG/PPG-14/14 Dimethicone, C12-15 Alkyl Benzoate, Ozokerite, VP/Eicosene Copolymer, Disteardimonium Hectorite, Glycoproteins*, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Caprooyl Tetrapeptide-3, Kigelia Africana Fruit Extract, Polymethylsilsesquioxane, Trifolium Pratense (Clover) Flower Extract, Caffeine, Alchemilla Vulgaris Extract, Ilomastat, Humulus Lupulus (Hops) Extract, Salvia Officinalis (Sage) Leaf Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Camellia Sinensis Leaf Extract, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Ammonium Glycyrrhizate, Octyldodecanol, Dimethicone, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Dextran, Lactic Acid, Sucrose, Allantoin, Hydrogenated Lecithin, Sodium Hyaluronate, Hydrolyzed Soy Protein, Ursolic Acid, Phenyl Trimethicone, Silica, Boron Nitride, Zinc Gluconate, Isododecane, Glycerin, Hylene Glycol, Propylene Glycol, Dipropylene Glycol, Pentylene Glycol, Isohexadecane, Xanthan Gum, Dipropylene Glycol Dibenzoate, Caprylyl Methicone, Magnesium Sulfate, Caprylyl Glycol, Polyglyceryl-10 Laurate, Cocamidopropyl PG-Dimonium Chloride Phosphate, Sodium Chloride, Hexyl Laurate, Mannitol, Polyglyceryl-2 Isostearate, Polysorbate 20, PEG-8, Polysorbate 60, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Carbonate, Trisodium EDTA, PPG-15 Stearyl Ether Benzoate, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Methylisothiazolinone, Titanium Dioxide (CI 77891), Mica, Iron Oxides (CI 77491, CI 77492, CI 77499) (i71)

Other Information

Protect the product in this container from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-821-5718 or visit www.laprairie.com

LABORATOIRES LA PRAIRIE S.A.

CLARENS/MONTREUX • ZURICH D-76530 BADEN-BADEN MILANO • PARIS LA PRAIRIE, INC., DISTR. NEW YORK, N.Y. 10019

ANTI-AGING CONCEALER FACE • EYES ILLUMINATEUR ANTI-AGE VISAGE • YEUX SUNSCREEN • CREME SOLAIRE SPF 20 la prairie SWITZERLAND 7.5 ml e / 0.25 FL. OZ. MADE IN USA

Product Labels

Anti Aging Concelear 1Drug FactsCarton

ANTI-AGING CONCEALER FACE EYES SUNSCREEN SPF 20 SHADE 40 
octinoxate, octisalate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68026-534
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE5 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
BUTYLENE GLYCOL 
HYDROGENATED POLYBUTENE (1300 MW) 
CYCLOMETHICONE 6 
ALKYL (C12-15) BENZOATE 
CERESIN 
ASIAN GINSENG 
EQUISETUM ARVENSE TOP 
CAPROOYL TETRAPEPTIDE-3 
KIGELIA AFRICANA FRUIT 
TRIFOLIUM PRATENSE FLOWER 
CAFFEINE 
ALCHEMILLA XANTHOCHLORA FLOWERING TOP 
ILOMASTAT 
HOPS 
SAGE 
HORSE CHESTNUT 
GREEN TEA LEAF 
AMMONIUM GLYCYRRHIZATE 
OCTYLDODECANOL 
DIMETHICONE 
LACTIC ACID 
SUCROSE 
ALLANTOIN 
HYDROGENATED SOYBEAN LECITHIN 
HYALURONATE SODIUM 
URSOLIC ACID 
PHENYL TRIMETHICONE 
SILICON DIOXIDE 
BORON NITRIDE 
ZINC GLUCONATE 
ISODODECANE 
GLYCERIN 
HEXYLENE GLYCOL 
PROPYLENE GLYCOL 
DIPROPYLENE GLYCOL 
PENTYLENE GLYCOL 
ISOHEXADECANE 
XANTHAN GUM 
DIPROPYLENE GLYCOL DIBENZOATE 
CAPRYLYL TRISILOXANE 
MAGNESIUM SULFATE 
CAPRYLYL GLYCOL 
POLYGLYCERYL-10 LAURATE 
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE 
SODIUM CHLORIDE 
HEXYL LAURATE 
MANNITOL 
POLYSORBATE 20 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 60 
PROPYLENE CARBONATE 
EDETATE TRISODIUM 
PPG-15 STEARYL ETHER BENZOATE 
PHENOXYETHANOL 
METHYLISOTHIAZOLINONE 
TITANIUM DIOXIDE 
MICA 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:68026-534-757.5 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/22/2013
Labeler - La Prairie, Inc. (092848621)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Laboratories, Inc001535103manufacture(68026-534)
Establishment
NameAddressID/FEIBusiness Operations
Equinox Packaging609261169manufacture(68026-534)

Revised: 10/2013
 
La Prairie, Inc.