ADVANCED ANTI-AGING EYE BROAD SPECTRUM SPF 37 SUPERGOOP- octinoxate, zinc oxide cream

Advanced Anti-Aging Eye Broad Spectrum SPF 37 by

Drug Labeling and Warnings

Advanced Anti-Aging Eye Broad Spectrum SPF 37 by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES, LTD., Cosway Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Octinoxate 7.5% Sunscreen

Zinc Oxide 10.1% Sunscreen

Uses Helps Prevent Sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Keep out of reach of children. If 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 eye. Rinse with water to remove.

Directions Apply Liberally 15 minutes before sun exposure

Use a water resistant if swimming or sweating

Reapply at least every 2 hours

Children under 6 months: Ask a doctor

Sun Protection Measures

Spending time in the sun increases your risk of early skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF calue of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m.-2p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Water, Ethylhexyl Stearate, Cyclopentasiloxane, Propanediol, Butylene Glycol, C12-15 Alkyl Benzoate, Potassium Cetyl Phosphate, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Isohexadecane, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Mica, Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Imperata Cylindrica Root Extract, Titanium Dioxide, Ceteareth-20, Squalane, Glycerin, Triethoxycaprylylsilane, Xanthan Gum, Helianthus Annuus (Sunflower) Seed Oil, Polysorbate 60, Trisodium Ethylene Disuccinate, Chlorphenesin, Citric Acid, Dimethicone, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Oleth-3 Phosphate, PEG-8, Punica Granatum Seed Oil, Avena Sativa (Oat) Peptide, Silica, Camellia Sinensis Leaf Extract, Carbomer, Olea Europaea (Olive) Fruit Extract, Euterpe Oleracea Fruit Extract, Methylisothiazolinone, Tocotrienols, Lauroyl Lysine.

PRINCIPAL DISPLAY PANEL

Advanced Anti-Aging Eye Cream Broad Spectrum SPF 37

Wrinkle-reducing oat peptide complex

Supergoop!

Opthamologist tested for sensitive eye area.

0.5 fl. oz./15 ml.

INGREDIENTS AND APPEARANCE

ADVANCED ANTI-AGING EYE BROAD SPECTRUM SPF 37  SUPERGOOP
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
SQUALANE (UNII: GW89575KF9)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XANTHAN GUM (UNII: TTV12P4NEE)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
CHLORPHENESIN (UNII: I670DAL4SZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
SAFFLOWER OIL (UNII: 65UEH262IS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
BLACK OLIVE (UNII: 2M6QWV94OC)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TOCOTRIENOLS (UNII: KP2MW85SSQ)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-120-02	1 in 1 CARTON	01/02/2013
1	NDC: 75936-120-01	15 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 75936-120-03	2 mL in 1 TUBE; Type 0: Not a Combination Product	01/02/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/02/2013

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc		620899877	manufacture(75936-120)