STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION- octinoxate and titanium dioxide cream

STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION by

Drug Labeling and Warnings

STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, 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., MANA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 7.00%	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

water\aqua\eau, cyclopentasiloxane, glycerin, butylene glycol, octyldodecyl neopentanoate, peg/ppg-18/18 dimethicone, polymethylsilsesquioxane, isostearic acid, c4-24 alkyl dimethicone/divinyldimethicone crosspolymer, isononyl isononanoate, tamarindus indica seed extract, tocopherol, tocopheryl acetate, sodium hyaluronate, haberlea rhodopensis leaf extract, beta vulgaris (beet) root extract\beta vulgaris\extrait de racine de betterave, butyrospermum parkii (shea butter), yeast extract\faex\extrait de levure, quercus suber bark extract, phytantriol, dextrin palmitate, dextrin palmitate/ethylhexanoate, cellulose gum, tetrahexyldecyl ascorbate, xanthan gum, dimethicone, methicone, propylene carbonate, sodium chloride, palmitic acid, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, hexyl laurate, polymethyl methacrylate, octyldodecyl pca, disteardimonium hectorite, stearic acid, caprylyl glycol, dipropylene glycol, phenoxyethanol, aluminum stearate, hexylene glycol [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), chromium oxide greens (ci 77288)] <iln35219>

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 - 40 ML Tube Carton

MAC

STUDIO SCULPT
SPF 15
FOUNDATION
BROAD SPECTRUM
SPF 15

40 ML/1.3 US FL OZ e

INGREDIENTS AND APPEARANCE

STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07194 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0227 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ISOSTEARIC ACID (UNII: X33R8U0062)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BEET (UNII: N487KM8COK)
SHEA BUTTER (UNII: K49155WL9Y)
PHYTANTRIOL (UNII: 8LVI07A72W)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHICONE (20 CST) (UNII: 6777U11MKT)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PALMITIC ACID (UNII: 2V16EO95H1)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MICA (UNII: V8A1AW0880)
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: 40046-0065-1	1 in 1 CARTON	09/01/2011
1		40 mL 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	09/01/2011

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0065) , REPACK(40046-0065)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0065)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0065)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0065)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0065)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(40046-0065) , REPACK(40046-0065)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(40046-0065) , REPACK(40046-0065)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0065)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0065)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		032870270	MANUFACTURE(40046-0065)