LE VELVET FILM MAKEUP REFILL SPF 15- octisalate, titanium dioxide paste 
Physicians Formula Inc

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.

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drug facts

Warnings: For external use only.Do not use on broken or damaged skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients: Octinoxate 7.5%, Octisalate 4.0%, Oxybenzone 4.0%

Purpose: Sunscreen

image of carton

LE VELVET FILM MAKEUP REFILL  SPF 15
octisalate, titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE23 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31645-129-021 in 1 BOX
1NDC:31645-129-0111 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2000
Labeler - Physicians Formula Inc (021261805)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Formula Inc825048945manufacture(31645-129)

Revised: 12/2012
Document Id: 64b7910d-31f6-47c4-a46f-1b7a1c110b50
Set id: 531e3977-626e-4434-b337-9cdb9f998426
Version: 1
Effective Time: 20121227
 
Physicians Formula Inc