Drug Facts

SOLAR POWDER SPF 20- titanium dioxide powder
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

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 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 Ingredient: Titanium Dioxide 3% Purpose: Sunscreen

SOLAR POWDER SPF 20
titanium dioxide powder

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:31645-140-01	9 g in 1 BOX

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

Labeler - Physicians Formula Inc (021261805)

Registrant - Physicians Formula Inc (021261805)

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