GLYTONE BODY- octinoxate, oxybenzone, avobenzene, octocrylene lotion

Glytone Body by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Sunscreen Active Ingredients

Octinoxate 7.50%

Oxybenzone 3.00%

Avobenzone 2.00%

Octocrylene 1.86%

PURPOSE

Purpose

Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early aging caused by the sun

Skin exfoliant

Skin moisturizer

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

For external use only

Keep out of reach of children

Do  not swallow. If swallowed, get medical help or contact Poison Control right away

Children under 6 months: ask a doctor before use.

DOSAGE & ADMINISTRATION

Directions

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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am- 2 pm, wear long sleeve shirts, pants, hats and sunglasses.

INACTIVE INGREDIENT

Ingredients that do not prevent Sunburn (Inactive Ingredients):

Water (aqua), Glycolic Acid, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Sodium Hydroxide, Glycerin, PEG-100 Stearate, Glceryl Stearate, Cetearyl Alcohol, Cyclotetrasiloxane, PEB-150 Stearate, Cetyl Alcohol, Dimethiconol, Cholesterol, Butyrosperum Parkii (Shea) Butter, Polyacrylamide, Phenoxyethanol, Cetearyl Glucoside, C13-14 Isoparaffin, Methylparaben, Xanthan Gum, Disodium ETA, Tocopheryl Acetate, Laureth-7

PRINCIPAL DISPLAY PANEL

Glytone Body

retexturize body lotion

broad spectrum

sunscreen SPF 15

glycolic complex

12 fl. oz/355 ml.

Pierre Fabre

Distributed by: Genesis Pharmaceutical, Inc.

Parsippany, NJ 07054

Made in USA

1-800-459-8663

www.glytone-usa.com

INGREDIENTS AND APPEARANCE

GLYTONE BODY 
octinoxate, oxybenzone, avobenzene, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-408
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	26.63 mL  in 355 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	10.65 mL  in 355 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	7.1 mL  in 355 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6.6 mL  in 355 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCOLIC ACID (UNII: 0WT12SX38S)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
PEG-150 STEARATE (UNII: 7BSG7DF10Q)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SHEA BUTTER (UNII: K49155WL9Y)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
METHYLPARABEN (UNII: A2I8C7HI9T)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAURETH-7 (UNII: Z95S6G8201)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-408-02	355 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/12/2012

Labeler - Genesis Pharmaceutical (784338563)

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