![VIRTUAL MATTE OIL CONTROL MAKEUP BROAD SPECTRUM SPF 15 (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [PRESCRIPTIVES INC]](https://medic.hrt.org//dailymed/images/7ca37428-978e-4312-8564-a6ace5fb4dcd/prescriptive-01.jpg)
| NDC | 59158-915-01 |
| Set ID | 7ca37428-978e-4312-8564-a6ace5fb4dcd |
| Category | HUMAN OTC DRUG LABEL |
| Packager | PRESCRIPTIVES INC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
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Warnings
For external use only
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least 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 • cyclopentasiloxane • butylene glycol • peg-10 dimethicone • trimethylsiloxysilicate • dimethicone • magnesium sulfate • dimethicone/peg-10/15 crosspolymer • laminaria saccharina extract • algae extract • acetyl hexapeptide-8 • sodium hyaluronate • cholesterol • ceramide 2 • linoleic acid • tocopheryl • acetate • hydrogenated lecithin • sorbitan sesquioleate • polysilicone-11 • phenyl trimethicone • lecithin • peg/ppg-18/ 18 dimethicone • disteardimonium hectorite • triethoxycaprylylsilane • propylene carbonate • silica • dimethicone/peg-10 crosspolymer • xanthan gum • laureth-7 • methyl methacrylate crosspolymer • methoxy amodimethicone/ silsesquioxane copolymer • dipropylene glycol • bht • chloroxylenol • phenoxyethanol • methylparaben • propylparaben • [+/- mica • iron oxides (ci 77491, ci 77492, ci 77499) • titanium dioxide (ci 77891)] <ILN37462>
- Other information
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
VIRTUAL MATTE OIL CONTROL MAKEUP BROAD SPECTRUM SPF 15
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59158-915 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.02775 g in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.010767 g in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) butylene glycol (UNII: 3XUS85K0RA) dimethicone (UNII: 92RU3N3Y1O) magnesium sulfate (UNII: DE08037SAB) saccharina latissima (UNII: 68CMP2MB55) acetyl hexapeptide-8 (UNII: L4EL31FWIL) hyaluronate sodium (UNII: YSE9PPT4TH) cholesterol (UNII: 97C5T2UQ7J) ceramide 2 (UNII: C04977SRJ5) linoleic acid (UNII: 9KJL21T0QJ) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) sorbitan sesquioleate (UNII: 0W8RRI5W5A) phenyl trimethicone (UNII: DR0K5NOJ4R) peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794) disteardimonium hectorite (UNII: X687XDK09L) triethoxycaprylylsilane (UNII: LDC331P08E) propylene carbonate (UNII: 8D08K3S51E) silicon dioxide (UNII: ETJ7Z6XBU4) xanthan gum (UNII: TTV12P4NEE) laureth-7 (UNII: Z95S6G8201) dipropylene glycol (UNII: E107L85C40) butylated hydroxytoluene (UNII: 1P9D0Z171K) chloroxylenol (UNII: 0F32U78V2Q) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) 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:59158-915-01 1 in 1 CARTON 1 30 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/01/2003 Labeler - PRESCRIPTIVES INC (151701588) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(59158-915) , REPACK(59158-915) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(59158-915) , RELABEL(59158-915) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(59158-915) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(59158-915) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(59158-915) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(59158-915) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(59158-915) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(59158-915) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 RELABEL(59158-915) , REPACK(59158-915)
