NDC | 31645-203-01 |
Set ID | 83fffc1a-81d5-4226-e053-2a91aa0aff13 |
Category | HUMAN OTC DRUG LABEL |
Packager | Physicians Formula, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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INGREDIENTS AND APPEARANCE
MURUMURU BUTTER LIP CREAM SPF 15
avobenzone, octinoxate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:31645-203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.1 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4.5 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3.6 mg in 1 g Inactive Ingredients Ingredient Name Strength TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ISOSTEARYL HYDROXYSTEARATE (UNII: F7540880P0) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARMINIC ACID (UNII: CID8Z8N95N) MANGANESE VIOLET (UNII: 72M48QQV8Q) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) TRIMETHYLOLPROPANE TRIISOSTEARATE (UNII: Y32A6D7C6L) CANDELILLA WAX (UNII: WL0328HX19) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIISOSTEARYL CITRATE (UNII: 50XT325OOH) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ASTROCARYUM ACULEATUM SEED OIL (UNII: JUP28JPX3K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SHEA BUTTER (UNII: K49155WL9Y) JOJOBA OIL (UNII: 724GKU717M) LOW DENSITY POLYETHYLENE (UNII: J245LN42AI) OCTYLDODECANOL (UNII: 461N1O614Y) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM) D&C RED NO. 28 (UNII: 767IP0Y5NH) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:31645-203-01 3.4 g in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2019 Labeler - Physicians Formula, Inc. (021261805)