SUN PROTECTION EMULSION FACE- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Sun Protection Emulsion Face by

Drug Labeling and Warnings

Sun Protection Emulsion Face by is a Otc medication manufactured, distributed, or labeled by Juvena GMBH, 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

- Helps prevent sunburn

- for skin that burns easily

-provides moderate protection against sunburn

-higher SPF gives more sunburn protection

Keep out of reach of children.

Do not use on infants under 6 months of age.

Stop use and ask a doctor if rash or irritation develops and lasts.

when using this product keep out of eyes.

rinse with water to remove.

Apply daily after cleansing and toning .

Smooth over face and throat.

Apply evenly before sun exposure.

Reapply as needed or after towel drying, swimming or perspiring.

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 Hyaluronate, Corallina Officinalis Extract, Sea Water ( Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dimethoxydimethylindanone, sodium hydroxide, porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Pakmata 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, Propyparaben

PRINCIPAL DISPLAY PANEL

Sun protection emulsion face SPF 30


125mL/ 4.2 FL. OZ.

INGREDIENTS AND APPEARANCE

SUN PROTECTION EMULSION FACE   LA PRAIRIE
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59614-221
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 mL  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	Octisalate	2.5 mL  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	2.4 mL  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Hexyldecanol (UNII: 151Z7P1317)
Dimethicone (UNII: 92RU3N3Y1O)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
STEARETH-21 (UNII: 53J3F32P58)
CETYL ALCOHOL (UNII: 936JST6JCN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARETH-2 (UNII: V56DFE46J5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
squalane (UNII: GW89575KF9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
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: 59614-221-11	0.088 mL in 1 DRUM
2	NDC: 59614-221-02	1 in 1 BOX
2	NDC: 59614-221-01	125 mL in 1 BOTTLE

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

Labeler - Juvena GMBH (315053785)

Registrant - Juvena GMBH (315053785)

Establishment
Name	Address	ID/FEI	Business Operations
Temmentec Ag		480586411	manufacture