Label: CELLULAR SWISS UV PROTECTION VEIL SUNSCREEN BROAD SPECTRUM SPF 50 LA PRAIRIE- octinoxate, oxybenzone, titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68807-310-01, 68807-310-02, 68807-310-03 - Packager: Temmentec Ag
- Category: HUMAN OTC DRUG LABEL
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 healthcare professional or from the pharmaceutical industry please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
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. - 2p.m.
Wear long sleeve shirts, pants, hats and sunglasses
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INACTIVE INGREDIENT
Inactive ingredients: Water(Aqua), C12-15 Alkyl Benzoate, Butylene Glycol, Ethylhexyl Methoxycrylene, Sorbitan Stearate, HDI/Trimethylol Hexylactone Crosspolymer, Polyhydroxystearic Acid, Cetearyl Alcohol, PEG/PPG/Polybutene Glycol-8/5/3 Glycerin, Squalane, Nylon-12, Glycolproteins, Panax Ginseng Root extract, Equisetum Arvense Extract, Polysorbate 80, Glycerin, Caprylyl/Capryl Glucoside, Sodium Hyaluronate, Leontopdodium Alpinum Extract, Rosa multifora Fruit Extract, Glycyrrhiza Glabra (licorice) Root Extract, Sodium Methyl Stearoyl Taurate, Tocopheryl Acetate, Ethylhexyglycerin, Hydroxypropyl Methylcellulose Stearoxy Ether, Xanthan Gum, Hibiscus Sabdariffa Flower Extract, Morus Alba Bark Extract, Cucumis Sativus (cucumber) seed Extract, Lecithin, Lactobacillus Ferment, Lysophosphatidic Acid, Sacharomyces Cerevisiae Extract, Triethoxycaprylylsilane, Alumina, Methicone, Alcohol, Silica, Citric Acid, BHT, Fragrance (parfum) Linalool, Benzyl Alcohol, Hydroxycitronellal, Citronellol, Alpa-isomethyl ionone, Amyl Cinnamal, Hexyl Cinnamal, Evernia Furfuracea (Treemoss) Extract, Benzyl Benzoate, Geraniolm Butylphenyl Methylpropional, Eugenol, Benzyl Salicylate, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Methylparaben, Yellow 5 (CI 19140), Red 40 (CI16035), Yellow 6 (CI 15985)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CELLULAR SWISS UV PROTECTION VEIL SUNSCREEN BROAD SPECTRUM SPF 50 LA PRAIRIE
octinoxate, oxybenzone, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-310 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.9 in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 18.6 in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SQUALANE (UNII: GW89575KF9) NYLON-12 (UNII: 446U8J075B) GLYCOPROTEIN HORMONES ALPHA CHAIN (UNII: 8YJ68CQ409) ASIAN GINSENG (UNII: CUQ3A77YXI) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWER (UNII: MWN6IZU3XM) ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27) LICORICE (UNII: 61ZBX54883) SODIUM METHYL STEAROYL TAURATE (UNII: JFM219LJ55) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) XANTHAN GUM (UNII: TTV12P4NEE) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) MORUS ALBA BARK (UNII: 7O71A48NDP) CUCUMBER SEED (UNII: BT3S9L53JK) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) LACTOBACILLUS REUTERI (UNII: 9913I24QEE) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM OXIDE (UNII: LMI26O6933) METHICONE (20 CST) (UNII: 6777U11MKT) ALCOHOL (UNII: 3K9958V90M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LINALOOL, (+)- (UNII: F4VNO44C09) BENZYL ALCOHOL (UNII: LKG8494WBH) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K) BENZYL BENZOATE (UNII: N863NB338G) GERANIOL (UNII: L837108USY) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) EUGENOL (UNII: 3T8H1794QW) BENZYL SALICYLATE (UNII: WAO5MNK9TU) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68807-310-02 1 in 1 CARTON 08/12/2015 1 NDC:68807-310-01 50 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:68807-310-03 5 mL in 1 JAR; Type 0: Not a Combination Product 08/12/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/12/2015 Labeler - Temmentec Ag (480586411) Registrant - Temmentec Ag (480586411) Establishment Name Address ID/FEI Business Operations Temmentec Ag 480586411 manufacture(68807-310)
