![MAC PRO LONGWEAR SPF 20 COMPACT FOUNDATION BROAD SPECTRUM SPF 20 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [MAKEUP ART COSMETICS]](https://medic.hrt.org//dailymed/images/11cbc7c6-d65e-4283-91d8-a1f74226bda3/mac-pro-01.jpg)
| NDC | 40046-0071-1 |
| Set ID | 11cbc7c6-d65e-4283-91d8-a1f74226bda3 |
| 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
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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:
- children under 6 months of age: ask a doctor
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inactive ingredients
dimethicone, nylon-12, polyethylene, dimethicone crosspolymer, isododecane, dimethicone silylate, tocopheryl acetate, sodium hyaluronate, butyrospermum parkii (shea butter), caryocar brasiliense fruit oil, persea gratissima (avocado) oil, olea europaea (olive) fruit oil, ceramide 2, ethylhexylglycerin, ethylhexyl palmitate, cetyl peg/ppg-10/1 dimethicone, phytosterols, alumina, silica dimethyl silylate, triethoxycaprylylsilane, butylene glycol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499)] <iln40537>
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 10 g Jar Carton
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INGREDIENTS AND APPEARANCE
MAC PRO LONGWEAR SPF 20 COMPACT FOUNDATION BROAD SPECTRUM SPF 20
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0071 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.4 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.3 g in 100 g Inactive Ingredients Ingredient Name Strength dimethicone (UNII: 92RU3N3Y1O) nylon-12 (UNII: 446U8J075B) high density polyethylene (UNII: UG00KM4WR7) isododecane (UNII: A8289P68Y2) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) hyaluronate sodium (UNII: YSE9PPT4TH) shea butter (UNII: K49155WL9Y) caryocar brasiliense fruit oil (UNII: WDI9AGC94F) avocado oil (UNII: 6VNO72PFC1) olive oil (UNII: 6UYK2W1W1E) ceramide 2 (UNII: C04977SRJ5) ethylhexylglycerin (UNII: 147D247K3P) ethylhexyl palmitate (UNII: 2865993309) aluminum oxide (UNII: LMI26O6933) silica dimethyl silylate (UNII: EU2PSP0G0W) triethoxycaprylylsilane (UNII: LDC331P08E) butylene glycol (UNII: 3XUS85K0RA) pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS) 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:40046-0071-1 1 in 1 CARTON 1 10 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/01/2014 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(40046-0071) , REPACK(40046-0071) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(40046-0071) , RELABEL(40046-0071) , REPACK(40046-0071) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(40046-0071) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(40046-0071) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(40046-0071) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(40046-0071) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(40046-0071) , RELABEL(40046-0071) , REPACK(40046-0071) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(40046-0071) , RELABEL(40046-0071) , REPACK(40046-0071) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(40046-0071) , RELABEL(40046-0071) , REPACK(40046-0071) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(40046-0071) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(40046-0071) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(40046-0071) , RELABEL(40046-0071)
