NDC | 40046-0066-1 |
Set ID | e30a2607-fa7e-4ed3-8c10-ac8ee1136c3d |
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
-
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply every two hours
- use a water resistant sunscreen if swimming or sweating
-
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
-
inactive ingredients
water\aqua\eau, cyclopentasiloxane, polymethyl methacrylate, butylene glycol, peg-10 dimethicone, trimethylsiloxysilicate, dimethicone, magnesium sulfate, tocopherol, tocopheryl acetate, sodium hyaluronate, lecithin, hydrogenated lecithin, algae extract, laminaria saccharina extract, dipropylene glycol, xanthan gum, laureth-7, sorbitan sesquioleate, dimethicone/peg-10/15 crosspolymer, dimethicone/peg-10 crosspolymer, peg/ppg-18/18 dimethicone, triethoxycaprylylsilane, dimethicone silylate, dimethicone crosspolymer, silica, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, chloroxylenol, phenoxyethanol, sorbic acid [+/- iron oxides (ci 77491, ci 77492, ci 77499), titanium dioxide (ci 77891), chromium oxide greens (ci 77288)] <iln37902>
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 35 ML Bottle Carton
-
INGREDIENTS AND APPEARANCE
MATCHMASTER SPF 15 FOUNDATION BROAD SPECTRUM
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0066 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.03723 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.01095 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) DIPROPYLENE GLYCOL (UNII: E107L85C40) XANTHAN GUM (UNII: TTV12P4NEE) LAURETH-7 (UNII: Z95S6G8201) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CHLOROXYLENOL (UNII: 0F32U78V2Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBIC ACID (UNII: X045WJ989B) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CHROMIC OXIDE (UNII: X5Z09SU859) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0066-1 1 in 1 CARTON 06/01/2011 1 35 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 06/01/2011 Labeler - MAKEUP ART COSMETICS (010597206) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 MANUFACTURE(40046-0066) , REPACK(40046-0066) , RELABEL(40046-0066) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 REPACK(40046-0066) , RELABEL(40046-0066) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 MANUFACTURE(40046-0066) , REPACK(40046-0066) , RELABEL(40046-0066) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 RELABEL(40046-0066) , REPACK(40046-0066) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 MANUFACTURE(40046-0066) , REPACK(40046-0066) , RELABEL(40046-0066) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 REPACK(40046-0066) , RELABEL(40046-0066) Establishment Name Address ID/FEI Business Operations NORTHTEC PALC 102631997 REPACK(40046-0066) , RELABEL(40046-0066) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 MANUFACTURE(40046-0066) , REPACK(40046-0066) , RELABEL(40046-0066) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 REPACK(40046-0066) , RELABEL(40046-0066)