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Package Insert and Label Information: Fresh Sugar Honey Tinted Lip Treatment SPF15

By Guerlain | Last revised: 31 December 2010

FRESH SUGAR HONEY TINTED LIP TREATMENT SPF15 — 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

HONEY TINTED LIP TREATMENT SPF 15

4.3 g 0.15oz

Fresh Inc Boston 02118 USA

image of carton
(click image for full-size original)
FRESH SUGAR HONEY TINTED LIP TREATMENT SPF15
octinoxate and oxybenzone lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49817-1987
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
Jojoba Oil
Castor Oil
1-Decanol
Grape Seed Oil
Carnauba Wax
Titanium Dioxide
Avocado Oil
Ferric Oxide Red
Meadowfoam Seed Oil
Glycyrrhizin, Ammoniated
Passiflora Incarnata Seed Oil
Polyglycerin-3
D&C Red No. 7
Vanillin
Butylated Hydroxytoluene
Vitamin A Palmitate
Tetrahexyldecyl Ascorbate
Alpha-Tocopherol
Ribes Nigrum Seed Oil
Sunflower Oil
Propyl Gallate
Ascorbyl Palmitate
Ricinoleic Acid
Isostearic Acid
Ferrosoferric Oxide
Aluminum Oxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49817-1987-4 1 CARTRIDGE (CARTRIDGE) in 1 CARTON contains a CARTRIDGE (49817-1987-8)
1 NDC:49817-1987-8 4.3 g in 1 CARTRIDGE This package is contained within the CARTON (49817-1987-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2011
Labeler — Guerlain (395158322)

Revised: 12/2010 Guerlain

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