GLYTONE ESSENTIALS REJUVENATE DAILY- avobenzone, octinoxate cream

Glytone essentials rejuvenate daily by

Drug Labeling and Warnings

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

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients

Water (Aqua), Glycolic Acid, Cyclomethicone, Ammonium Hydroxide, Butyl Salicylate, Glyceryl Stearate, Butlylene Glycol, Ethylhexyl Palmitate, Pentaerythrityl Tetraisostearate, Cetearyl Alcohol, PEG-150 Stearate, Hydrogenated Avocado Oil, Cetyl Alcohol, Dimethiconol, Glycine Soja (soybean) sterols, Butyrospermum parkii (Shea butter), Petrolatum, Silica, Phenoxyethanol, Dicetyl Phosphate, Glycerin, Tocopheryl Acetate, Disodium EDTA, Xanthan Gum, Hydrolyzed Collagen, Hyaluronic Acid

ACTIVE INGREDIENT

Active Ingredients                  Purpose

Avobenzone 2.00%                  Sunscreen

Octinoxate 6.00%                       Sunscreen

PURPOSE

Purpose   Sunscreen

INFORMATION FOR PATIENTS

Other Information

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

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.
Children under 6 months; ask doctor.

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 sun.

KEEP OUT OF REACH OF CHILDREN

For external use only. Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

Apply in the morning to cleansed face and neck or as directed by 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 SPF value of 15 or higher and other sun protection measures including: limite time in the sun, specially from 10 am to 2pm. Wear long-sleeved shirts, pants, hats and sunglasses.

PRINCIPAL DISPLAY PANEL

Glytone Essentials

rejuvenate

daily cream

broad spectrum

sunscreen SPF 15

Glycolic complex

50 ml e/net wt. 1.7 oz. (50 g)

Lightweight, oil-free cream combines glycolic acid, vitamin E and other clinically proven ingredients with SPF15 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.
Shea Butter, Avocado Oil and glycerin-Emollients that sooth the skin.
Hydrolyzed Collagen and Hyaluronic acid-Anti-aging ingredients that moisturize skin and give it volume and fullness.

Exclusive to physicians
Pierre Fabre
Distributed by: Genesis Pharmactical, Inc
Parsippany, NY  07054
Made in USA
1-800-459-8663
www.glytone-use.com

INGREDIENTS AND APPEARANCE

GLYTONE ESSENTIALS REJUVENATE DAILY 
avobenzone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	1 mL  in 50 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCOLIC ACID (UNII: 0WT12SX38S)
CYCLOMETHICONE (UNII: NMQ347994Z)
AMMONIA (UNII: 5138Q19F1X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
AVOCADO OIL (UNII: 6VNO72PFC1)
CETYL ALCOHOL (UNII: 936JST6JCN)
SOYBEAN (UNII: L7HT8F1ZOD)
SHEA BUTTER (UNII: K49155WL9Y)
PETROLATUM (UNII: 4T6H12BN9U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PHOSPHATE ION (UNII: NK08V8K8HR)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-204-01	1 in 1 BOX
1		50 mL in 1 JAR

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

Labeler - Glytone (117196928)

Establishment
Name	Address	ID/FEI	Business Operations
Genesis Pharmaceutical		784338563	manufacture