FRESH SUGAR ROSE TINTED LIP TREATMENT SPF 15- octinoxate and oxybenzone lipstick

Fresh Sugar Rose Tinted Lip Treatment SPF 15 by

Drug Labeling and Warnings

Fresh Sugar Rose Tinted Lip Treatment SPF 15 by is a Otc medication manufactured, distributed, or labeled by Guerlain. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Octinoxate 7.49%

                                 Oxybenzone 2%

WARNINGS

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

PRINCIPAL DISPLAY PANEL

Fresh

SUGAR

ROSE TINTED LIP TREATMENT SPF 15

4.3 g      0.15oz

Fresh Inc Boston 02118 USA

INGREDIENTS AND APPEARANCE

FRESH SUGAR ROSE TINTED LIP TREATMENT SPF 15 
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49817-1988
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.49 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
White Wax (UNII: 7G1J5DA97F)
Jojoba Oil (UNII: 724GKU717M)
Castor Oil (UNII: D5340Y2I9G)
1-Decanol (UNII: 89V4LX791F)
Grape Seed Oil (UNII: 930MLC8XGG)
Carnauba Wax (UNII: R12CBM0EIZ)
Avocado Oil (UNII: 6VNO72PFC1)
Meadowfoam Seed Oil (UNII: 412ZHA4T4Y)
FD&C Yellow No. 6 (UNII: H77VEI93A8)
Titanium Dioxide (UNII: 15FIX9V2JP)
D&C Red No. 7 (UNII: ECW0LZ41X8)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Polyglycerin-3 (UNII: 4A0NCJ6RD6)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Alpha-Tocopherol (UNII: H4N855PNZ1)
Rosa Damascena Flower (UNII: JWB78P295A)
Ribes Nigrum Seed Oil (UNII: GKE1188837)
Ferric Oxide Red (UNII: 1K09F3G675)
Sunflower Oil (UNII: 3W1JG795YI)
Propyl Gallate (UNII: 8D4SNN7V92)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Ricinoleic Acid (UNII: I2D0F69854)
Isostearic Acid (UNII: X33R8U0062)
Aluminum Oxide (UNII: LMI26O6933)
Ferrosoferric Oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49817-1988-4	1 in 1 CARTON
1	NDC: 49817-1988-8	4.3 g in 1 CARTRIDGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2009

Labeler - Guerlain (395158322)