Fresh Sugar Rose Tinted Lip Treatment SPF 15

Dosage form: lipstick
Ingredients: Octinoxate 7.49g in 100g, Oxybenzone 2.0g in 100g
Labeler: Guerlain
NDC Code: 49817-1988

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

ROSE TINTED LIP TREATMENT SPF 15


4.3 g      0.15oz

Fresh Inc Boston 02118 USA


FRESH SUGAR ROSE TINTED LIP TREATMENT SPF 15 
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49817-1988
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate7.49 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
White Wax 
Jojoba Oil 
Castor Oil 
1-Decanol 
Grape Seed Oil 
Carnauba Wax 
Avocado Oil 
Meadowfoam Seed Oil 
FD&C Yellow No. 6  
Titanium Dioxide 
D&C Red No. 7  
Butylated Hydroxytoluene 
Polyglycerin-3 
Vitamin A Palmitate 
Tetrahexyldecyl Ascorbate 
Alpha-Tocopherol 
Rosa Damascena Flower  
Ribes Nigrum Seed Oil 
Ferric Oxide Red 
Sunflower Oil 
Propyl Gallate 
Ascorbyl Palmitate 
Ricinoleic Acid 
Isostearic Acid 
Aluminum Oxide 
Ferrosoferric Oxide 
Packaging
#Item CodePackage Description
1NDC:49817-1988-41 CARTRIDGE (CARTRIDGE) in 1 CARTON
1NDC:49817-1988-84.3 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2009
Labeler - Guerlain (395158322)

Revised: 12/2010
 
Guerlain

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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