CELLULAR SWISS UV PROTECTION VEIL SUNSCREEN BROAD SPECTRUM SPF 50 LA PRAIRIE- octinoxate, oxybenzone, titanium dioxide, zinc oxide cream

Cellular Swiss UV Protection Veil Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Cellular Swiss UV Protection Veil Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Temmentec Ag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients           Purpose

Octinoxate 7.5%            Sunscreen

Oxybenzone 5.0%         Sunscreen

Titanium Dioxide 1.9%   Sunscreen

Zinc Oxide18.6%            Sunscreen

PURPOSE

helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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

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

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

Cellular Swiss UV Protection Veil

Sunscreen Broad Spectrum SPF 50

La Prairie Switzerland

50 ml/ 1.7 FL. OZ.

INGREDIENTS AND APPEARANCE

CELLULAR SWISS UV PROTECTION VEIL SUNSCREEN BROAD SPECTRUM SPF 50  LA PRAIRIE
octinoxate, oxybenzone, titanium dioxide, zinc oxide cream

Product 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)