MINERALIZE SPF 15 FOUNDATION LOOSE- titanium dioxide powder

MINERALIZE by

Drug Labeling and Warnings

MINERALIZE by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation, CRYSTAL CLAIRE COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: TITANIUM DIOXIDE 7.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: MICA [] HORDEUM DISTICHON (BARLEY) EXTRACT\EXTRAIT D'ORGE A DEUX RANGS [] TRITICUM VULGARE (WHEAT) GERM OIL [] ASCORBYL PALMITATE [] TOCOPHERYL ACETATE [] SQUALANE [] METHICONE [] POTASSIUM SORBATE [] CHLORPHENESIN []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 (CI 42090) [] CARMINE (CI 75470) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] CHROMIUM OXIDE GREENS (CI 77288) [] FERRIC FERROCYANIDE (CI 77510) [] YELLOW 5 LAKE (CI 19140) [] ZINC OXIDE (CI 77947)

WARNINGS

WARNING: KEEP OUT OF EYES. DISCONTINUE USE IF IRRITATION DEVELOPS. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

MAC

MINERALIZE

SPF 15 FOUNDATION

LOOSE

8.5  g/ 0.30 US oz



makeup art cosmetics distr.
toronto, CANADA M3J 2W3

INGREDIENTS AND APPEARANCE

MINERALIZE  SPF 15 FOUNDATION LOOSE
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
BARLEY BRAN (UNII: 2TXV6Z67KP)
WHEAT GERM OIL (UNII: 14C97E680P)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SQUALANE (UNII: GW89575KF9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
COCHINEAL (UNII: TZ8Z31B35M)
CHROMIC OXIDE (UNII: X5Z09SU859)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0031-1	1 in 1 CARTON
1	NDC: 40046-0031-2	8.5 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2007

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		205952385	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aramis Inc.		042918826	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Bristol		949264774	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		618107429	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd		253616536	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Distribution Center		208579636	repack, relabel

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Kabushiki Kaisha		712808195	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Whitman Laboratories Ltd.		216866277	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
CRYSTAL CLAIRE COSMETICS		205493484	manufacture