NDC | 68759-003-01, 68759-003-02 |
Set ID | 74d28465-56a5-49c6-a49a-1ea42f4addf3 |
Category | HUMAN OTC DRUG LABEL |
Packager | AMERICAN BEAUTY COSMETICS |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INGREDIENTS: WATER [] PHENYL TRIMETHICONE [] BUTYLENE GLYCOL [] PENTAERYTHRITYL TETRAETHYLHEXANOATE [] SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [] PETROLATUM [] BIOSACCHARIDE GUM - 1 [] STEARETH-21 [] GLYCERYL STEARATE [] SODIUM HYALURONATE [] TOCOPHERYL ACETATE [] POLYMETHYL METHACRYLATE [] MAGNESIUM ALUMINUM SILICATE [] ETHYLHEXYLGLYCERIN [] CAPRYLYL GLYCOL [] CETYL ALCOHOL [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] PEG-12 DIMETHICONE [] ISOHEXADECANE [] LECITHIN [] ALUMINA [] XANTHAN GUM [] STEARETH-2 [] POTASSIUM STEARATE [] CITRIC ACID [] FRAGRANCE (PARFUM) [] LIMONENE [] LINALOOL [] BENZYL SALICYLATE [] POLYSORBATE 80 [] DISODIUM EDTA [] PHENOXYETHANOL [] SORBIC ACID [] [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
YOUTH FULL TINTED MOISTURIZER SPF 15
octinoxate, titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68759-003 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) JOJOBA OIL (UNII: 724GKU717M) PETROLATUM (UNII: 4T6H12BN9U) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) STEARETH-21 (UNII: 53J3F32P58) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL ALCOHOL (UNII: 936JST6JCN) ISOHEXADECANE (UNII: 918X1OUF1E) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ALUMINUM OXIDE (UNII: LMI26O6933) XANTHAN GUM (UNII: TTV12P4NEE) STEARETH-2 (UNII: V56DFE46J5) POTASSIUM STEARATE (UNII: 17V812XK50) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBIC ACID (UNII: X045WJ989B) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68759-003-01 1 in 1 CARTON 1 NDC:68759-003-02 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2010 Labeler - AMERICAN BEAUTY COSMETICS (143367634) 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