STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35- octinoxate and titanium dioxide paste

STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35 by

Drug Labeling and Warnings

STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35 by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, Estee Lauder Companies Inc., Whitman Laboratories Ltd., ESTEE LAUDER COMPANY, THE, Estee Lauder Cosmetics Ltd., Estee Lauder N.V., NORTHTEC INC, NORTHTEC PALC, Len-Ron Manufacturing Division of Aramis Inc., PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 5.00%	Sunscreen
Titanium Dioxide 2.00%	Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply every two hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m
  • wear long-sleeved shirts, pants, hats and sunglasses.
• children under 6 months of age: ask a doctor

inactive ingredients

octyldodecanol, synthetic beeswax, copernicia cerifera (carnauba) wax, silica, hydrogenated polyisobutene, simmondsia chinensis (jojoba) seed oil, tocopherol, ascorbyl palmitate, polybutene, pvp/hexadecene copolymer, alumina, stearic acid [+/-(may contain) titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), chromium oxide greens (ci 77288)] <iln28455>

Other information

protect the product in this container from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7

PRINCIPAL DISPLAY PANEL - 7 g Jar Carton

MAC

STUDIO FINISH
CONCEALER
SPF 35
BROAD SPECTRUM
SPF 35

NET WT. 7 g/.24 US OZ e

INGREDIENTS AND APPEARANCE

STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35 
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0078
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 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHROMIC OXIDE (UNII: X5Z09SU859)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0078-1	1 in 1 CARTON	08/08/2011
1		7 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/08/2011

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0078) , REPACK(40046-0078)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0078)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0078)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0078)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0078)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(40046-0078) , REPACK(40046-0078)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(40046-0078) , REPACK(40046-0078)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0078)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0078)