Label: MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREEN- octinoxate, titanium dioxide, and zinc oxide liquid
- NDC Code(s): 40046-0075-1
- Packager: MAKEUP ART COSMETICS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 31, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply every two hours
- use a water resistant sunscreen if swimming or sweating
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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
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton
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INGREDIENTS AND APPEARANCE
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREEN
octinoxate, titanium dioxide, and zinc oxide liquidProduct 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 final M020 08/01/2015 Labeler - MAKEUP ART COSMETICS (010597206) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(40046-0075) , pack(40046-0075) , label(40046-0075)
