NDC | 62874-995-01, 62874-995-02 |
Set ID | 0b24eb0e-21f5-4359-8a38-f02846106d99 |
Category | HUMAN OTC DRUG LABEL |
Packager | JO MALONE LTD, Distr. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VITAMIN E LIP CONDITIONER SPF 15
octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62874-995 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.5 in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62874-995-01 1 in 1 CARTON 1 NDC:62874-995-02 15 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2003 Labeler - JO MALONE LTD, Distr. (347366049) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations PADC 1 110482184 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 manufacture, label, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture