ANTI-AGING COMPLEX EYE TREATMENT MERLE NORMAN- octinoxate, zinc oxide lotion

Anti-Aging Complex Eye Treatment by

Drug Labeling and Warnings

Anti-Aging Complex Eye Treatment by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Octinoxate 7.4% Sunscreen

Zinc Oxide 6.5% 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 eyes. Rinse with water to remove.

Directions

For sunscreen

- apply liberally and evenly 15 minutes before sun exposure

- use a water resistant sunscreen if swimming

- reapply at least every 2 hours

Sun Protection Measures. Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk of skin cancer, 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-sleeved shirts, pants, hats, and sunglasses

children under six months: Ask a doctor

Inactive ingredients

Water (Aqua), Glycerin, Butyrospermum Parkii (Shea Butter), Squalane, Cyclopentasiloxane, Isononyl Myristate, Pentylene Glycol,
C12-15 Alkyl Benzoate, Isopropyl Myristate, Cetearyl Alcohol, Glyceryl Stearate, Nylon-12, PEG-100 Stearate, Ceteareth-20, Polyacrylamide,
Acetyl Octapeptide-3, Acetylarginyltryptophyl Diphenylglycine, Palmitoyl Tetrapeptide-7, Medicago Sativa (Alfafa) Seed Extract,
Euphrasia Officinalis Extract, Retinyl Palmitate, Ascorbyl Palmitate, Tocopheryl Acetate, Dimethicone Crosspolymer, Cyclomethicone,
Cyclotetrasiloxane, Ethylhexyl palmitate, Propylene Glycol, Butylene Glycol, Caprylyl Glycol, Sodium Hyaluronate, Hesperidin Methyl Chalcone, Ceramide-2, Hydrolyzed Lupine Protein, Hydrolyzed Vegetable Protein, Adenosine Triphosphate, Acetyl Tyrosine, Phospholipids, C13-14 Isoparaffin, Proline, Tribehenin, Triethoxycaprylylsilane, PEG-30 Dipolyhydroxypropyl, Laureth-7, Steareth-20 PEG-10 Rapeseed Sterol, Xanthan Gum, Hydroxypropyl Cyclodextrin, PVP, BHT Silica, Silica Dimethyl Silylate, Trisodium EDTA, Benzyl Alcohol, Tropolone Chlorphenesin, Phenoxyethanol, Titanium Dioxide, Mica.

PRINCIPAL DISPLAY PANEL

Anti-Aging Complex Eye Treatment

Broad Spectrum

Merle Norman

established in Los Angeles since 1931

16 g Net Wt. .55 oz

INGREDIENTS AND APPEARANCE

ANTI-AGING COMPLEX EYE TREATMENT   MERLE NORMAN
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.18 g  in 16 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.04 g  in 16 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
SQUALANE (UNII: GW89575KF9)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
NYLON-12 (UNII: 446U8J075B)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
ACETYL OCTAPEPTIDE-3 (UNII: 8K14HJF88S)
VALYLTRYPTOPHAN (UNII: 3G64B4AFQN)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ALFALFA SEED (UNII: 67PHZ58858)
EUPHRASIA STRICTA (UNII: C9642I91WL)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X)
CERAMIDE 2 (UNII: C04977SRJ5)
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)
N-ACETYLTYROSINE (UNII: DA8G610ZO5)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PROLINE (UNII: 9DLQ4CIU6V)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
LAURETH-7 (UNII: Z95S6G8201)
STEARETH-20 (UNII: L0Q8IK9E08)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
EDETATE TRISODIUM (UNII: 420IP921MB)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TROPOLONE (UNII: 7L6DL16P1T)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-150-02	1 in 1 CARTON	11/09/2012
1	NDC: 57627-150-01	16 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 not final	part352	11/09/2012

Labeler - Merle Norman Cosmetics (008479388)

Registrant - Merle Norman Cosmetics (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics		008479388	manufacture(57627-150)