LIP CONDITIONER SPF 15- octinoxate lipstick

LIP CONDITIONER SPF 15 by

Drug Labeling and Warnings

LIP CONDITIONER SPF 15 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNING

Stop use if irritation occurs.

ACTIVE INGREDIENT

OCTINOXATE 3.50%

INGREDIENTS

RICINUS COMMUNIS (CASTOR) SEED OIL CAPRYLIC/CAPRIC TRIGLYCERIDE EUPHORBIA CERIFERA (CANDELILLA) WAX BIS-DIGLYCERYL POLYACYLADIPATE-2 CETYL ACETATE BEESWAX (CERA ALBA) MICA POLYETHYLENE OLEYL OLEATE COPERNICIA CERIFERA (CARNAUBA) WAX BUTYROSPERMUM PARKII (SHEA BUTTER) POLYDECENE LANOLIN OIL BARIUM SULFATE POLYGLYCERYL-3 DIISOSTEARATE TOCOPHERYL ACETATE ASCORBYL PALMITATE LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER ACETYLATED LANOLIN ALCOHOL ALUMINA BHT <ILN25993>

SPL UNCLASSIFIED SECTION

©ESTĒE LAUDER, DIST. NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 3.8 g Lipstick Carton

EL

ESTĒE LAUDER

Lip
Conditioner

SPF 15

NET WT.
.13 OZ./3.8 g e

INGREDIENTS AND APPEARANCE

LIP CONDITIONER SPF 15 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-725
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CANDELILLA WAX (UNII: WL0328HX19)
CETYL ACETATE (UNII: 4Q43814HXS)
YELLOW WAX (UNII: 2ZA36H0S2V)
MICA (UNII: V8A1AW0880)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OLEYL OLEATE (UNII: 3X3L452Y85)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
LANOLIN OIL (UNII: OVV5IIJ58F)
BARIUM SULFATE (UNII: 25BB7EKE2E)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-725-01	1 in 1 CARTON
1		3.8 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/1998

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL(11559-725) , REPACK(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(11559-725) , RELABEL(11559-725) , REPACK(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(11559-725) , RELABEL(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE(11559-725) , RELABEL(11559-725) , REPACK(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE(11559-725) , RELABEL(11559-725) , REPACK(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE(11559-725) , RELABEL(11559-725) , REPACK(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-725)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(11559-725)