![MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREEN (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LIQUID [MAKEUP ART COSMETICS]](https://medic.hrt.org//dailymed/images/e5fd3e40-de1d-4cdd-b725-4a517514ca35/mac-01.jpg)
| NDC | 40046-0075-1 |
| Set ID | e5fd3e40-de1d-4cdd-b725-4a517514ca35 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | MAKEUP ART COSMETICS |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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 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)
