Label: 2 IN 1 POWDER MAKE-UP SPF 15- octinoxate titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-057-21, 68828-057-25 - Packager: JAFRA COSMETICS INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 11, 2012
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- ACTIVE INGREDIENT
- PURPOSE
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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
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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