FRESH SUGAR PLUM 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.

----------

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

PLUM TINTED LIP TREATMENT SPF 15


4.3 g       0.15oz

Fresh Inc Boston 02118 USA



image of carton
FRESH SUGAR PLUM TINTED LIP TREATMENT SPF 15 
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49817-1989
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.49 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
White Wax (UNII: 7G1J5DA97F)  
Castor Oil (UNII: D5340Y2I9G)  
Jojoba Oil (UNII: 724GKU717M)  
1-Decanol (UNII: 89V4LX791F)  
Grape Seed Oil (UNII: 930MLC8XGG)  
Carnauba Wax (UNII: R12CBM0EIZ)  
Avocado Oil (UNII: 6VNO72PFC1)  
Meadowfoam Seed Oil (UNII: 412ZHA4T4Y)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Polyglycerin-3 (UNII: 4A0NCJ6RD6)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
Alpha-Tocopherol (UNII: H4N855PNZ1)  
Ribes Nigrum Seed Oil (UNII: GKE1188837)  
Sunflower Oil (UNII: 3W1JG795YI)  
Propyl Gallate (UNII: 8D4SNN7V92)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
FD&C Yellow No. 6 (UNII: H77VEI93A8)  
D&C Red No. 7 (UNII: ECW0LZ41X8)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Glycyrrhizin, Ammoniated (UNII: 3VRD35U26C)  
FD&C Yellow No. 5 (UNII: I753WB2F1M)  
Vanillin (UNII: CHI530446X)  
Passiflora Incarnata Seed Oil (UNII: S0SU5AC95J)  
Isostearic Acid (UNII: X33R8U0062)  
Aluminum Oxide (UNII: LMI26O6933)  
Ricinoleic Acid (UNII: I2D0F69854)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49817-1989-41 in 1 CARTON
1NDC:49817-1989-94.3 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2010
Labeler - Guerlain (395158322)

Revised: 12/2010
Document Id: 8ed54a06-b651-42cc-8e30-f287b2c9831a
Set id: 3dd79c5c-b17b-432b-920c-86dd06396348
Version: 2
Effective Time: 20101231
 
Guerlain