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

Le Velvet Film Makeup Refill by

Drug Labeling and Warnings

Le Velvet Film Makeup Refill by is a Otc medication manufactured, distributed, or labeled by Physicians Formula Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

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

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

ACTIVE INGREDIENT

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

Purpose: Sunscreen

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LE VELVET FILM MAKEUP REFILL  SPF 15
octisalate, titanium dioxide paste

Product 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)