ULTRA PROTECTION STICK BROAD SPECTRUM SPF 40 LA PRAIRIE SWITZERLAND- avobenzone, homosalate, octisalate, oxybenzone stick

Ultra Protection Stick Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Ultra Protection Stick Broad Spectrum SPF 40 by is a Otc medication manufactured, distributed, or labeled by Temmentec Ag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients      Purpose

Avobenzone 3%       Sunscreen

Homosalate 7%        Sunscreen

Octisalate 5%           Sunscreen

Oxybenzone 2%       Sunscreen

Uses

helps prevent sunburn

warning

Keep out of reach of children

Indications

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

 apply liberally 15 minutes befor e 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

Polyethylene, Petrolatum, C12-15 Alkyl Benzoate, Caprylyl Methicone, Aluminum Starch Octenylsuccinate, Butyloctyl Salicylate, Polyester-8, Simmondsia Chinensis (Jojoba) Butter, Water (Aqua), ButyrospermumParkii (Shea Butter), Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Beeswax (Cera Alba), VP/Eicosene Copolymer, Pelvetia Canaliculata Extract, Sodium Lactate, Palmaria Palmata Extract, Behenyl Olivate, Lecithin, Porphyra Umbilicalis Extract, Ammonium Glycyrrhizate, Algae Extract, Benzylidene Dimethoxydimethylindanone, Dipropylene Glycol, BHT, Alcohol, Butylene Glycol, Phenoxyethanol

PRINCIPAL DISPLAY PANEL

Ultra Protection Stick

Eye - Lip -  Nose

Sunscreen Broad Spectrum

Stick Solaire Haute Protection

Yeux - Levres - Nez

Creme Solaire

Large Spectre

SPF 40

la prarie Switzerland

10 g/ Net Wt. 0.35 OZ

Made in Switzerland Fabrique en Suisse

INGREDIENTS AND APPEARANCE

ULTRA PROTECTION STICK BROAD SPECTRUM SPF 40  LA PRAIRIE SWITZERLAND
avobenzone, homosalate, octisalate, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68807-309
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 350 (UNII: ZBR3T82M2V)
PETROLATUM (UNII: 4T6H12BN9U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
JOJOBA BUTTER (UNII: XIA46H803R)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
ASIAN GINSENG (UNII: CUQ3A77YXI)
WHITE WAX (UNII: 7G1J5DA97F)
PELVETIA CANALICULATA (UNII: 8U1M44KESN)
SODIUM LACTATE (UNII: TU7HW0W0QT)
DULSE (UNII: 7832HOY4ZQ)
BEHENYL OLIVATE (UNII: NGS1GGK4GW)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68807-309-02	1 in 1 BOX
1	NDC: 68807-309-01	10 g in 1 BOTTLE; 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	04/04/2013

Labeler - Temmentec Ag (480586411)

Registrant - Temmentec Ag (480586411)

Establishment
Name	Address	ID/FEI	Business Operations
Temmentec Ag		480586411	manufacture(68807-309)