EVEN BETTER COMPACT MAKEUP BROAD SPECTRUM SPF15- titanium dioxide cream

EVEN BETTER COMPACT MAKEUP by

Drug Labeling and Warnings

EVEN BETTER COMPACT MAKEUP by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Titanium Dioxide 3.80%

Purpose

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 at least 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 doctor

Inactive ingredients

ethylhexyl palmitate silica phenyl trimethicone cetyl dimethicone tribehenin squalane glycereth-8 hydroxystearate trimethylsiloxysilicate arachidyl propionate ozokerite lauryl methacrylate/glycol dimethacrylate crosspolymer tetrahexyldecyl ascorbate ascorbyl palmitate trihydroxystearin tocopheryl acetate caprylyl glycol sorbitan sesquioleate triethoxycaprylylsilane simethicone disteardimonium hectorite [+/- iron oxides (ci 77491, ci 77492, ci 77499) titanium dioxide (ci 77891) zinc oxide (ci 77947) mica] [iln39622]

Other information

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

SPL UNCLASSIFIED SECTION

DIST. NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 10 g Tube Carton

C

CLINIQUE

even better

compact makeup
broad spectrum
SPF 15
evens and corrects

POIDS NET WT. .35 OZ./ 10 g e

INGREDIENTS AND APPEARANCE

EVEN BETTER COMPACT MAKEUP   BROAD SPECTRUM SPF15
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
silicon dioxide (UNII: ETJ7Z6XBU4)
phenyl trimethicone (UNII: DR0K5NOJ4R)
tribehenin (UNII: 8OC9U7TQZ0)
squalane (UNII: GW89575KF9)
arachidyl propionate (UNII: QV5DAH3MSB)
lauryl methacrylate/glycol dimethacrylate crosspolymer (UNII: EX0F4CZ66H)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
ascorbyl palmitate (UNII: QN83US2B0N)
trihydroxystearin (UNII: 06YD7896S3)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
caprylyl glycol (UNII: 00YIU5438U)
sorbitan sesquioleate (UNII: 0W8RRI5W5A)
triethoxycaprylylsilane (UNII: LDC331P08E)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
zinc oxide (UNII: SOI2LOH54Z)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-018-01	1 in 1 CARTON	10/01/2012
1		10 g in 1 TUBE; 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	10/01/2012

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-018) , REPACK(49527-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-018)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-018)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-018) , REPACK(49527-018)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-018) , REPACK(49527-018)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-018)