GUERLAIN TERRACOTTA GLOSS 03 GRENADE- octinoxate lipstick
Guerlain S.A.

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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Guerlain Terracotta Gloss 03 Grenade

Active Ingredient

OCTINOXATE (ETHYLHEXYL METHOXYCINNAMATE) 7.4 %

Purpose

Sunscreen

Other Ingredients

TRIMETHYLOLPROPANE TRIISOSTEARATE, METHYL HYDROGENATED ROSINATE, DIMER DILINOLEYL DIMER DILINOLEATE, DIISOSTEARYL MALATE, TRIDECYL TRIMELLITATE, C18-36 ACID TRIGLYCERIDE, SYNTHETIC FLUORPHLOGOPITE, SILICA DIMETHYL SILYLATE, SCLEROCARYA BIRREA SEED OIL, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, PARFUM (FRAGRANCE), PROPYL GALLATE, BENZYL BENZOATE, BHT, TOCOPHEROL, ALUMINUM HYDROXIDE, ALPHA-ISOMETHYL IONONE, LIMONENE, SOLANUM LYCOPERSICUM (TOMATO) FRUIT/LEAF/STEM EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT[ C177891 (TITANIUM DIOXIDE), C1 77491, C1 77492, C1 77499 (IRON OXIDES), C1 15850 (RED 6, RED 6 LAKE, RED 7, RED 7 LAKE), C1 10140 (YELLOW 5 LAKE), C1 15985 (YELLOW 6 LAKE), C1 45410 (RED 28 LAKE), C1 42090 (BLUE 1 LAKE), C1 73360 (RED 30 LAKE), C1 45380 (RED 21 LAKE), C1 17200 (RED 33 LAKE), C1 77742 (MANGANESE VIOLET), C1 77163 (BISMUTH OXYCHLORIDE)]

For The Lips

Warning

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

Discontinue Use If Signs Of Irritation Appear

KEEP OUT OF REACH OF CHILDREN

Representative Labeling

GUERLAIN TERRACOTTA GLOSS 03 GRENADE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:49817-0015
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (OCTINOXATE)	OCTINOXATE	74 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
APRICOT SEED OIL
PROPYL GALLATE
BENZYL BENZOATE
BUTYLATED HYDROXYTOLUENE
ALUMINUM HYDROXIDE
TOMATO
SUNFLOWER OIL
ROSEMARY
TITANIUM DIOXIDE
D&C RED NO. 6
D&C RED NO. 7
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
D&C RED NO. 28
FD&C BLUE NO. 1
D&C RED NO. 30
D&C RED NO. 21
D&C RED NO. 33
BISMUTH OXYCHLORIDE

#	Item Code	Package Description
Packaging
1	NDC:49817-0015-1	5 mL in 1 TUBE
2	NDC:49817-0015-2	5 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/17/2010	04/09/2014

Labeler - Guerlain S.A. (395158322)

Name	Address	ID/FEI	Business Operations
Establishment
Guerlain S.A.		395158322	manufacture(49817-0015)

Revised: 4/2014

Document Id: fe171cef-841c-4a37-957b-63cdbbd5efab

Set id: 0272faae-6e47-4568-9427-e62184b102b3

Version: 10

Effective Time: 20140409

Guerlain S.A.