Label: LE VELVET FILM MAKEUP REFILL SPF 15- octisalate, titanium dioxide paste
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Contains inactivated NDC Code(s)
NDC Code(s): 31645-129-01, 31645-129-02 - Packager: Physicians Formula Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 27, 2012
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- WARNINGS AND PRECAUTIONS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LE VELVET FILM MAKEUP REFILL SPF 15
octisalate, titanium dioxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:31645-129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 23 g in 100 g Inactive Ingredients Ingredient Name Strength TRIDECYL STEARATE (UNII: A8OE252M6L) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) CARNAUBA WAX (UNII: R12CBM0EIZ) CERESIN (UNII: Q1LS2UJO3A) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ULTRAMARINE BLUE (UNII: I39WR998BI) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:31645-129-02 1 in 1 BOX 1 NDC:31645-129-01 11 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/01/2000 Labeler - Physicians Formula Inc (021261805) Establishment Name Address ID/FEI Business Operations Physicians Formula Inc 825048945 manufacture(31645-129)
