STUDIO FIX FLUID SPF 15- octinoxate, titanium dioxide lotion

STUDIO FIX FLUID by

Drug Labeling and Warnings

STUDIO FIX FLUID 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: OCTINOXATE 2.50% [] TITANIUM DIOXIDE 1.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] CYCLOPENTASILOXANE [] PEG-10 DIMETHICONE [] BUTYLENE GLYCOL [] TRIMETHYLSILOXYSILICATE [] DIMETHICONE [] MAGNESIUM SULFATE [] LAMINARIA SACCHARINA EXTRACT [] ALGAE EXTRACT [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] TOCOPHEROL [] LECITHIN [] HYDROGENATED LECITHIN [] XANTHAN GUM [] SORBITAN SESQUIOLEATE [] METHOXY AMODIMETHICONE/SILSESQUIOXANE COPOLYMER [] LAURETH-7 [] DIPROPYLENE GLYCOL [] DIMETHICONE/PEG-10/15 CROSSPOLYMER [] DIMETHICONE/PEG-10 CROSSPOLYMER [] PEG/PPG-18/18 DIMETHICONE [] DISTEARDIMONIUM HECTORITE [] SILICA [] DIMETHICONE CROSSPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] PROPYLENE CARBONATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] SORBIC ACID [] CHLOROXYLENOL [] PHENOXYETHANOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] CHROMIUM OXIDE GREENS (CI 77288)]

WARNINGS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

MAC

STUDIO FIX FLUID

SPF 15

1 FL OZ LIQ/ 30 ML

MAKEUP ART COSMETICS

TORONTO, ONTARIO, CANADA M5V 1R7

INGREDIENTS AND APPEARANCE

STUDIO FIX FLUID  SPF 15
octinoxate, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIMETHYLSILANE (UNII: 9L70DJH2K0)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
SEAWEED (UNII: 477TV3P5UX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
LAURETH-7 (UNII: Z95S6G8201)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SORBIC ACID (UNII: X045WJ989B)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CHROMIC OXIDE (UNII: X5Z09SU859)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0050-1	1 in 1 CARTON
1	NDC: 40046-0050-2	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2005

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