Label: ANTI-AGING EYE BROAD SPECTRUM SPF 15 LA PRAIRIE SWITZERLAND- avbenzone, octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68807-303-01, 68807-303-02, 68807-303-03 - Packager: Temmentec Ag
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated January 3, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 2.0% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 3.0% 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 under the eye and along the brow line
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 of 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), Cetearyl Alcohol, Soybean Glycerides, Butyrospermum Parkii (Shea Butter) Unsaponifiables, Polyethylene, Myristyl Myristate, Ethoxydiglycol, Butylene Glycol, Synthetic Beeswax, Glyceryl Caprylate, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Hesperetin Laurate, Saccharomyces/Xylinum/Black Tea Ferment, Tocopherol, Hydrolyzed Malt Extract, Lecithin, Olea Europaea (Olive) Oil Unsaponifiables, Ursolic Acid, Erythrityl Triethylhexanoate, Plankton Extract, Ilomastat, Carnosine, Echium Plantagineum Seed Oil, Carbomer, Caprylyl/Capryl Glucoside, Serine, Silybum Marianum Fruit Extract, Acacia Senegal Gum, Ascorbyl Tetraisopalmitate, Triticum Vulgare (Wheat) Germ Oil Unsaponifiables, Hydroxyethylcellulose, Lauroyl Lysine, Melissa Officinalis Leaf Extract, PEG-8, Pollen Extract, Hydrogenated Lecithin, Glycerin, Trehalose, Glycine Soja (Soybean) Oil Unsaponifiables, Polyquaternium-51, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-6 Isostearate, Propylene Glycol, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Urea, Sodium PCA, Isodecyl Salicylate, Tocopheryl Linoleate/Oleate, Algin, Disodium EDTA, Isopropylbenzyl Salicylate, Steareth-2, Phospholipids, DNA, Polyisobutene, Ceteth-20, Xanthan Gum, Triacetin, Mica, Cyclomethicone, Polymethyl Methacrylate, Steareth-21, Cyclohexasiloxane, Sucrose, Stearic Acid, Alcohol, Aluminum Hydroxide, Fragrance (Parfum), Benzyl Alcohol, Linalool, Hydroxycitronellal, Alpha-Isomethyl Ionone, Amyl Cinnamal, Hexyl Cinnamal, Evernia Furfuracea (Treemoss) Extract, Geraniol, Benzyl Benzoate, Butylphenyl Methylpropional, Phenoxyethanol, Benzoic Acid, Methylparaben, Potassium Sorbate, Chlorphenesin, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, Titanium Dioxide (CI 77891)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI-AGING EYE BROAD SPECTRUM SPF 15 LA PRAIRIE SWITZERLAND
avbenzone, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-303 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SHEA BUTTER (UNII: K49155WL9Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) GLYCERYL CAPRATE (UNII: 197M6VFC1W) ASIAN GINSENG (UNII: CUQ3A77YXI) EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) HESPERETIN LAURATE (UNII: HP864VLN2T) TOCOPHEROL (UNII: R0ZB2556P8) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) URSOLIC ACID (UNII: P3M2575F3F) CARNOSINE (UNII: 8HO6PVN24W) ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW) CARBOMER 934 (UNII: Z135WT9208) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) SERINE (UNII: 452VLY9402) MILK THISTLE (UNII: U946SH95EE) ACACIA (UNII: 5C5403N26O) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) LAUROYL LYSINE (UNII: 113171Q70B) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) GLYCERIN (UNII: PDC6A3C0OX) TREHALOSE (UNII: B8WCK70T7I) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) PEG-6 ISOSTEARATE (UNII: 0E2639OTJY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) UREA (UNII: 8W8T17847W) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SODIUM ALGINATE (UNII: C269C4G2ZQ) EDETATE DISODIUM (UNII: 7FLD91C86K) ISOPROPYLBENZYL SALICYLATE (UNII: 0798EIC152) STEARETH-2 (UNII: V56DFE46J5) CETETH-20 (UNII: I835H2IHHX) XANTHAN GUM (UNII: TTV12P4NEE) TRIACETIN (UNII: XHX3C3X673) MICA (UNII: V8A1AW0880) CYCLOMETHICONE (UNII: NMQ347994Z) STEARETH-21 (UNII: 53J3F32P58) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SUCROSE (UNII: C151H8M554) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BENZYL ALCOHOL (UNII: LKG8494WBH) LINALOOL, (+)- (UNII: F4VNO44C09) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) GERANIOL (UNII: L837108USY) BENZYL BENZOATE (UNII: N863NB338G) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZOIC ACID (UNII: 8SKN0B0MIM) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CHLORPHENESIN (UNII: I670DAL4SZ) ETHYLPARABEN (UNII: 14255EXE39) BUTYLPARABEN (UNII: 3QPI1U3FV8) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68807-303-02 1 in 1 CARTON 01/14/2013 1 NDC:68807-303-01 15 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:68807-303-03 5 mL in 1 TUBE; Type 0: Not a Combination Product 01/14/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/14/2013 Labeler - Temmentec Ag (480586411) Registrant - Temmentec Ag (480586411) Establishment Name Address ID/FEI Business Operations Temmentec Ag 480586411 manufacture(68807-303)