SOLAR POWDER SPF 20- titanium dioxide powder

Solar Powder by

Drug Labeling and Warnings

Solar Powder by is a Otc medication manufactured, distributed, or labeled by Physicians Formula Inc, Tecnocosmesi SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WHEN USING

Warning:  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

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 Ingredient: Titanium Dioxide 3%  Purpose:  Sunscreen

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOLAR POWDER  SPF 20
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31645-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Talc (UNII: 7SEV7J4R1U)
Dimethicone (UNII: 92RU3N3Y1O)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Mineral Oil (UNII: T5L8T28FGP)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
Dehydroacetic Acid (UNII: 2KAG279R6R)
Sorbic Acid (UNII: X045WJ989B)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
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: 31645-140-01	9 g in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2005

Labeler - Physicians Formula Inc (021261805)

Registrant - Physicians Formula Inc (021261805)

Establishment
Name	Address	ID/FEI	Business Operations
Tecnocosmesi SA		435445218	manufacture