Guerlain Terracotta Gloss 01 Sable

GUERLAIN TERRACOTTA GLOSS 01 SABLE- 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 01 Sable

ACTIVE INGREDIENT:   OCTINOXATE (ETHYLHEXYL METHOXYCINNAMATE) 7.4%

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 EYS.

DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR.

KEEP OUT OF REACH OF CHILDREN

COPYRIGHT GUERLAIN
68, CHAMPS-ELYSEES
75008 PARIS
www.guerlain.com

MADE IN FRANCE

In USA: 19E57 NY. NY10022

ACTIVE INGREDIENT: OCTINOXATE 7.4%

IP/SPF 15

01

G552810

MADE IN FRANCE

24 M

In USA: 19E57 NY. NY10022

Guerlain Sable Cap


01

SABLE

TERRACOTTA GLOSS

GUERLAIN

TERRACOTTA GLOSS

MOISTURISING

SUN SHIMMER GLOSS

SPF 15

5ml .17 FL OZ


TerracottaGloss01Outer

GUERLAIN TERRACOTTA GLOSS 01 SABLE 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49817-0013
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE74 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49817-0013-15 mL in 1 TUBE
2NDC:49817-0013-25 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/17/201004/01/2014
Labeler - Guerlain S.A. (395158322)
Establishment
NameAddressID/FEIBusiness Operations
Guerlain S.A.395158322manufacture(49817-0013)

Revised: 4/2014
 
Guerlain S.A.