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

Sun Protection Emulsion Face Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Sun Protection Emulsion Face Broad Spectrum SPF 30 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

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.

PRINCIPAL DISPLAY PANEL

Sun Protection Emulsion Face

Emulsion Solaire Protectrice Visage

Sunscreen Broad Spectrum SPF 30

La Prairie Switzerland

125 ml 4.2 Fl. Oz.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68807-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.6 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.4 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68807-307-02	1 in 1 CARTON
1	NDC: 68807-307-01	125 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/14/2011

Labeler - Temmentec Ag (480586411)

Registrant - Temmentec Ag (480586411)

Establishment
Name	Address	ID/FEI	Business Operations
Temmentec Ag		480586411	manufacture(68807-307)