FRESH SUGAR ROSE TINTED 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.

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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

ROSE TINTED LIP TREATMENT SPF 15

4.3 g 0.15oz

Fresh Inc Boston 02118 USA

image of carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Guerlain (395158322)