Package Insert and Label Information: Fresh Sugar Lip Treatment SPF 15

By Guerlain | Last revised: 31 December 2010

FRESH SUGAR LIP TREATMENT SPF 15 — octinoxate and oxybenzone lipstick
Guerlain

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.

Active Ingredients: Octinoxate 7.49%

Oxybenzone 2%

Warnings: Avoid contact with the eyes. For external use only.

Keep out of reach of children. Discontinue use if signs

of irritation or rash appear. Contains Oxybenzone.

PRINCIPAL DISPLAY PANEL

Fresh

SUGAR

LIP TREATMENT SPF 15

4.3g 0.15oz

(click image for full-size original)

image of carton

FRESH SUGAR LIP TREATMENT SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49817-1990
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (Octinoxate)	Octinoxate	7.49 g in 100 g
Oxybenzone (Oxybenzone)	Oxybenzone	2.0 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
White Wax
Castor Oil
Jojoba Oil
1-Decanol
Grape Seed Oil
Carnauba Wax
Wheat Germ Oil
Avocado Oil
Meadowfoam Seed Oil
Butylated Hydroxytoluene
Vitamin A Palmitate
Tetrahexyldecyl Ascorbate
Alpha-Tocopherol
Ribes Nigrum Seed Oil
Sunflower Oil
Ascorbyl Palmitate
Apricot Seed Oil
Isostearic Acid

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:49817-1990-4	1 CARTRIDGE (CARTRIDGE) in 1 CARTON	contains a CARTRIDGE (49817-1990-8)
1	NDC:49817-1990-8	4.3 g in 1 CARTRIDGE	This package is contained within the CARTON (49817-1990-4)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2003

Labeler — Guerlain (395158322)

Revised: 12/2010 Guerlain