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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION

SUNSCREEN

Drug Facts

Active IngredientsPurpose
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:

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

DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
LONDON W1K 3BQ / MXCT

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton

M•A•C
STUDIO

STUDIO WATERWEIGHT
SPF 30 FOUNDATION
BROAD SPECTRUM SPF 30

30 ML/1.0 FL OZ e

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION  SUNSCREEN
octinoxate, titanium dioxide, and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0075
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05425 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.03364 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.02279 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0075-11 in 1 CARTON08/01/2015
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/01/2015
Labeler - MAKEUP ART COSMETICS (010597206)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326manufacture(40046-0075) , pack(40046-0075) , label(40046-0075)

Revised: 8/2023
Document Id: 043d1192-3156-a513-e063-6294a90a9298
Set id: e5fd3e40-de1d-4cdd-b725-4a517514ca35
Version: 7
Effective Time: 20230831
 
MAKEUP ART COSMETICS