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.

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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

HONEY TINTED LIP TREATMENT SPF 15


4.3 g      0.15oz

Fresh Inc Boston 02118 USA


image of carton

FRESH SUGAR HONEY TINTED LIP TREATMENT SPF15 
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49817-1987
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)  
Jojoba Oil (UNII: 724GKU717M)  
Castor Oil (UNII: D5340Y2I9G)  
1-Decanol (UNII: 89V4LX791F)  
Grape Seed Oil (UNII: 930MLC8XGG)  
Carnauba Wax (UNII: R12CBM0EIZ)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Avocado Oil (UNII: 6VNO72PFC1)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Meadowfoam Seed Oil (UNII: 412ZHA4T4Y)  
Glycyrrhizin, Ammoniated (UNII: 3VRD35U26C)  
Passiflora Incarnata Seed Oil (UNII: S0SU5AC95J)  
Polyglycerin-3 (UNII: 4A0NCJ6RD6)  
D&C Red No. 7 (UNII: ECW0LZ41X8)  
Vanillin (UNII: CHI530446X)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
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)  
Ricinoleic Acid (UNII: I2D0F69854)  
Isostearic Acid (UNII: X33R8U0062)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Aluminum Oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49817-1987-41 in 1 CARTON
1NDC:49817-1987-84.3 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2011
Labeler - Guerlain (395158322)

Revised: 12/2010
Document Id: 53cabb11-252a-44dd-b7dd-974e004e23aa
Set id: 1493ee87-fe0a-420f-af1c-3b9b5e5987a5
Version: 2
Effective Time: 20101231
 
Guerlain