NDC | 49527-005-01, 49527-005-02 |
Set ID | 361d7f45-22f4-440f-b9e6-312618e48298 |
Category | HUMAN OTC DRUG LABEL |
Packager | CLINIQUE LABORATORIES INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
inactive ingredients: water [] methyl trimethicone [] phenyl trimethicone [] dimethicone [] triethylhexanoin [] butylene glycol [] trimethylsiloxysilicate [] peg-10 dimethicone [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] aluminum hydroxide [] c12-15 alkyl benzoate [] lactobacillus ferment [] citrus grandis (grapefruit) peel extract [] magnolia grandiflora bark extract [] poria cocos sclerotium extract [] astrocaryum murumuru seed butter [] glycerin [] caffeine [] sodium myristoyl sarcosinate [] caprylyl methicone [] methicone [] polyglyceryl-6 polyricinoleate [] disteardimonium hectorite [] acetyl glucosamine [] isopropyl titanium triisostearate [] dimethicone crosspolymer-3 [] lecithin [] tocopheryl acetate [] laureth-7 [] dimethicone/peg-10/15 crosspolymer [] sodium chloride [] dipropylene glycol [] disodium edta [] polyaminopropyl biguanide [] phenoxyethanol [] [+/- mica [] titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499)] - WARNINGS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
REDNESS SOLUTIONS MAKEUP SPF 15 WITH PROBIOTIC TECHNOLOGY
octinoxate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5.9 mL in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.7 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.9 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) LACTOBACILLUS HELVETICUS (UNII: Q08Z44662J) CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6) MAGNOLIA GRANDIFLORA BARK (UNII: J4XF5T6418) FU LING (UNII: XH37TWY5O4) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) GLYCERIN (UNII: PDC6A3C0OX) CAFFEINE (UNII: 3G6A5W338E) SODIUM MYRISTOYL ISETHIONATE (UNII: 8D42TA2T6V) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LAURETH-7 (UNII: Z95S6G8201) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-005-01 1 in 1 CARTON 1 NDC:49527-005-02 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/01/2010 Labeler - CLINIQUE LABORATORIES INC (173047747) 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