GLYTONE ESSENTIALS REJUVENATE DAILY- avobenzone, octinoxate lotion

Glytone Essentials Rejuvenate daily by

Drug Labeling and Warnings

Glytone Essentials Rejuvenate daily by is a Otc medication manufactured, distributed, or labeled by Genesis Pharmaceutical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions

Apply in the morning to cleansed face and neck or as directed by your physician. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. 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 SFP value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

INactive Ingredients Water (Aqua), Glycolic Acid, Cyclomethicone, Butloctyl Salicylate, Glyceryl stearate, Glycerin, Stearoxy Dimethicone, Ammonium Hydroxide, PEG-150 Stearate, Cetyl Alcohol, Dimethiconol, Glycine Soja (Soybean), Sterols, Phenxyethanol, Xanthan Gum, Methyl-paraben, Polyacrylamide, Tocopheryl Acetate, Disodium EDTA, C13-14 Isoparaffin,Laureth-7.

ACTIVE INGREDIENT

Active Ingredients       Purpose

Avobenzone 2.0%        Sunscreen

Oxtinoxate 7.0%            Sunscreen

WARNINGS

Warnings

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. If pregnant or breast-feeding, ask a health professional before use. For external use only. Do not swallow. If swallowed, get medical help or contact Poison Control right away. Do not use on children under 2 years of age unless directed by a doctor.

INFORMATION FOR PATIENTS

Other Information

This product is not intended as a sunscreen for sunbathing use. Keep this product away from heat (above 30 C/86 F) and direct sunlight.

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

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

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

Lightweight, oil-free lotion combines glycolic acid vitamin E with SPF 15 broad spectrum protection. A unique, patented microvesicle delivery system slowly releases skin-enhancing glycolic acid and moisturizing agents throughout the day. Smoothes, softens and retexturizes skin for a healthy looking complexion.

Glytone essentials

Rejuvenate

Daily lotion

broad spectrum

sunscreen SPF 15

glycolic complex

60 ml/e/2 fl.oz

Exclusive to physicians

Pierre Fabre

Distributed by:

Genesis Pharmaceutical, Inc.

Parsippany, NJ 07054

Made in USA

1-800-459-8663

www.glytone-use.com

INGREDIENTS AND APPEARANCE

GLYTONE ESSENTIALS REJUVENATE DAILY 
avobenzone, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	4.2 mL  in 60 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	1.2 mL  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCOLIC ACID (UNII: 0WT12SX38S)
CYCLOMETHICONE (UNII: NMQ347994Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIA (UNII: 5138Q19F1X)
PEG-150 STEARATE (UNII: 7BSG7DF10Q)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)
SOY STEROL (UNII: PL360EPO9J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-203-01	60 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/20/2010

Labeler - Genesis Pharmaceutical (784338563)