HARMON FACE VALUES REVITALIZING DAY- avobenzone, octisalate and octocrylene cream

Harmon Face Values Revitalizing Day by

Drug Labeling and Warnings

Harmon Face Values Revitalizing Day by is a Otc medication manufactured, distributed, or labeled by Harmon Stores Inc., Emilia Personal Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 3.0%

Octisalate 5.0%

Octocrylene 10.0%

Purpose

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

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.

Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.

Children under 6 months of age: ask a doctor.

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-sleeved shirts, pants, hats and sunglasses

Inactive ingredients

water, disopropyl adipate, cyclopentasiloxane, glycerin, glyceryl stearate, PEG-100 stearate, titanium dioxide, alumina, simethicone, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, triethanolamine, acrylates/C10-30 aklyl acrylate crosspolymer, tocopheryl acetate (vitamin E), carbomer, disodium EDTA

Package/Label Principal Display Panel

HARMON®
FACEVALUESTM

REVITALIZING

BROAD SPECTRUM SPF 18 SUNSCREEN DAY CREAM

ADVANCED ANTI-WRINKLE &
FIRMING MOISTURIZER

with encapsulated Pro-Vitamin A,
Matrixyl® & Sepilift®

Distributed by
Harmon Stores, Inc.
650 Liberty Ave.
Union, NJ 07083 USA
Harmon Stores, Inc.
Visit us at:
www.facevalues.com
Manufactured in Israel
37815B1C1

Carton Label

INGREDIENTS AND APPEARANCE

HARMON FACE VALUES REVITALIZING DAY 
avobenzone, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-387
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-100 STEARATE (UNII: YD01N1999R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
JOJOBA OIL (UNII: 724GKU717M)
YELLOW WAX (UNII: 2ZA36H0S2V)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
STEARIC ACID (UNII: 4ELV7Z65AP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SOY ISOFLAVONES (UNII: 71B37NR06D)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARETH-2 (UNII: V56DFE46J5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
SOY PROTEIN (UNII: R44IWB3RN5)
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALLANTOIN (UNII: 344S277G0Z)
SQUALANE (UNII: GW89575KF9)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-387-15	1 in 1 CARTON
1		48 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/21/2012

Labeler - Harmon Stores Inc. (804085293)

Registrant - Emilia Personal Care Inc. (965445112)