STUDIO FOUNDATION SPF 15- octinoxate and titanium dioxide stick

STUDIO FOUNDATION SPF 15 by

Drug Labeling and Warnings

STUDIO FOUNDATION SPF 15 by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), Estee Lauder 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, Pennsylvania Logistics Center, PRIVATE LABEL SELECT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNING

KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

ACTIVE INGREDIENTS

OCTINOXATE 5.00%, TITANIUM DIOXIDE 2.90%

INGREDIENTS

DI-PPG-3-MYRISTYL ETHER ADIPATE, PHENYL TRIMETHICONE, SILICA, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE, TRIBEHENIN, C20-40 ALCOHOLS, ISONONYL ISONONANOATE, OZOKERITE, ALOE BARBADENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, ASCORBYL PALMITATE, RETINYL PALMITATE, LECITHIN, ALUMINUM STEARATE, TRIMETHYLSILOXYSILICATE, SORBITAN LAURATE, PROPYLENE GLYCOL LAURATE, PROPYLENE GLYCOL STEARATE, POLYSORBATE 20, STEARIC ACID [+/- TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)] <ILN29118>

SPL UNCLASSIFIED SECTION

DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7, LONDON W1K 3BQ.

PRINCIPAL DISPLAY PANEL - 9 g Tube Carton

MAC

STUDIO STICK FOUNDATION SPF 15

NET WT./POIDS NET 9 g/.31 US OZ e

INGREDIENTS AND APPEARANCE

STUDIO FOUNDATION SPF 15 
octinoxate and titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0057-1	1 in 1 CARTON
1		9 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/06/2003

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(40046-0057) , REPACK(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(40046-0057) , RELABEL(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(40046-0057) , RELABEL(40046-0057)

Establishment
Name	Address	ID/FEI	Business Operations
PRIVATE LABEL SELECT LTD		005415463	MANUFACTURE(40046-0057)