NDC | 11559-006-01, 11559-006-02 |
Set ID | 84c26bb5-b614-4e24-85e1-665135b42bbc |
Category | HUMAN OTC DRUG LABEL |
Packager | ESTEE LAUDER INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER\AQUA\EAU [] METHYL TRIMETHICONE [] BUTYLOCTYL SALICYLATE [] NEOPENTYL GLYCOL DIHEPTANOATE [] POLYESTER-8 [] ALEURITES MOLUCCANA (KUKUI) SEED OIL [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] PEG-100 STEARATE [] BUTYLENE GLYCOL [] GLYCERYL STEARATE [] DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE [] SCUTELLARIA BAICALENSIS ROOT EXTRACT [] PYRUS MALUS (APPLE) FRUIT EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT [] LAMINARIA OCHROLEUCA EXTRACT [] ACETYL GLUCOSAMINE [] CAFFEINE [] C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER [] SODIUM HYALURONATE [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] SORBITOL [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] CAPRYLYL GLYCOL [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] CETYL ALCOHOL [] POTASSIUM CETYL PHOSPHATE [] ETHYLHEXYLGLYCERIN [] VP/EICOSENE COPOLYMER [] STEARIC ACID [] FRAGRANCE (PARFUM) [] DEHYDROXANTHAN GUM [] DISODIUM EDTA [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL [] MICA
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CYBER WHITE BRILLIANT CELLS FULL SPECTRUM BRIGHTENING UV PROTECTOR SPF 50
homosalate, octisalate, avobenzone, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.0 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-006-01 1 in 1 CARTON 1 NDC:11559-006-02 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2010 Labeler - ESTEE LAUDER INC (005914387) 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 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 repack, 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