Label: HARMON FACE VALUES REVITALIZING DAY- avobenzone, octisalate and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 63940-387-15 - Packager: Harmon Stores Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 12, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
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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
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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
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Package/Label Principal Display Panel
HARMON®
FACEVALUESTMREVITALIZING
BROAD SPECTRUM SPF 18 SUNSCREEN DAY CREAM
ADVANCED ANTI-WRINKLE &
FIRMING MOISTURIZERwith 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
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INGREDIENTS AND APPEARANCE
HARMON FACE VALUES REVITALIZING DAY
avobenzone, octisalate and octocrylene creamProduct 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)