NDC | 68828-057-21, 68828-057-25 |
Set ID | 2aeb3745-bf6e-49ae-a151-d5d633ac6bbc |
Category | HUMAN OTC DRUG LABEL |
Packager | JAFRA COSMETICS INTERNATIONAL |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
-
INACTIVE INGREDIENT
OTHER INGREDIENTS: TALC, HYDROGENATED LECITHIN, DIMETHICONE, OCTYLDODECYL LACTATE, METHYL METHACRYLATE CROSSPOLYMER, SILICA, ZINC STEARATE, OCTYLDODECYL STEAROYL STEARATE, METHYLPARABEN, DIISOSTEAROYL POLYGLYCERYL-3 DIISOSTEARATE, PROPYLPARABEN, SODIUM PCA, TOCOPHERYL ACETATE, TRIMETHYLSILOXYAMODIMETHICONE, MICA, DIAZOLIDINYL UREA [MAY CONTAIN, +/-: IRON OXIDES/CI 77491/CI 77492/CI 77499]
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
2 IN 1 POWDER MAKE-UP SPF 15
octinoxate titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-057 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.25 g in 100 g Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) DIMETHICONE (UNII: 92RU3N3Y1O) OCTYLDODECYL LACTATE (UNII: 8JKW8M5W35) METHYL METHACRYLATE (UNII: 196OC77688) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ZINC STEARATE (UNII: H92E6QA4FV) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) METHYLPARABEN (UNII: A2I8C7HI9T) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) PROPYLPARABEN (UNII: Z8IX2SC1OH) TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN) MICA (UNII: V8A1AW0880) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-057-21 1 in 1 BOX 1 NDC:68828-057-25 12 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/24/2012 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479) Registrant - JAFRA COSMETICS INTERNATIONAL (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture