MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREEN- octinoxate, titanium dioxide, and zinc oxide liquid

MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION by

Drug Labeling and Warnings

MAC STUDIO WATERWEIGHT SPF 30 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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 5.0%	Sunscreen
Titanium Dioxide 3.1%	Sunscreen
Zinc Oxide 2.1%	Sunscreen

Use

helps prevent sunburn

Apply directly to face. Blend with finger, sponge or appropriate foundation brush.

Warnings

For external use only

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help 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, methyl trimethicone, phenyl trimethicone, silica, butyloctyl salicylate, dimethicone, neopentyl glycol diheptanoate, c12-15 alkyl benzoate, butylene glycol, dimethicone silylate, lauryl peg-9 polydimethylsiloxyethyl dimethicone, ethylhexyl palmitate, glycerin, polysilicone-11, citrullus vulgaris (watermelon) fruit extract, sodium hyaluronate, lecithin, pyrus malus (apple) fruit extract, lens esculenta (lentil) fruit extract, glycine soja (soybean) protein, litchi chinensis seed extract, laminaria saccharina extract, peg-10 dimethicone, tocopheryl acetate, methicone, trimethylsiloxysilicate, sodium pca, sodium lactate, thermus thermophillus ferment, triethyl citrate, laureth-7, silica dimethyl silylate, polymethylsilsesquioxane, magnesium aluminum silicate, xanthan gum, dimethicone/peg-10/15 crosspolymer, sodium chloride, dextrin, triethoxycaprylylsilane, disteardimonium hectorite, caprylyl glycol, hexylene glycol, polyglutamic acid, zinc stearate, disodium edta, phenoxyethanol, potassium sorbate, sodium dehydroacetate [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499)] <iln41311>

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
LONDON W1K 3BQ / MXCT

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton

MAC
STUDIO

STUDIO WATERWEIGHT
SPF 30 FOUNDATION
BROAD SPECTRUM SPF 30

30 ML/1.0 FL OZ e

INGREDIENTS AND APPEARANCE

MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION   SUNSCREEN
octinoxate, titanium dioxide, and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05425 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.03364 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.02279 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATERMELON (UNII: 231473QB6R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
APPLE (UNII: B423VGH5S9)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
SOYBEAN (UNII: L7HT8F1ZOD)
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM LACTATE (UNII: TU7HW0W0QT)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
LAURETH-7 (UNII: Z95S6G8201)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ICODEXTRIN (UNII: 2NX48Z0A9G)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ZINC STEARATE (UNII: H92E6QA4FV)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0075-1	1 in 1 CARTON	08/01/2015
1		30 mL in 1 BOTTLE; 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	08/01/2015

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0075) , REPACK(40046-0075)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0075)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0075)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V		370151326	MANUFACTURE(40046-0075)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0075)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(40046-0075) , REPACK(40046-0075)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(40046-0075) , REPACK(40046-0075)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0075)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0075)