HEALTHY WEAR PRESSED BRONZER SPF 50- octinoxate, titanium dioxide, zinc oxide powder

Healthy Wear Pressed Bronzer by

Drug Labeling and Warnings

Healthy Wear Pressed Bronzer by is a Otc medication manufactured, distributed, or labeled by Physicians Formula Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:  Octinoxate 4%, Titanium Dioxide 21%, Zinc Oxide 3%

Purpose: Sunscreen

PURPOSE

Uses . Helps prevent sunburn.  Higher SPF gives more sunburn protection . Retains SPF 50 after 40 minutes of activity in the water, sweating or perspiring

KEEP OUT OF REACH OF CHILDREN

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

WHEN USING

When using this product

• Keep out of eyes
• Rinse with water to remove
  

ASK DOCTOR

Stop use and ask a doctor if

• Rash or irritation develops and lasts
  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTHY WEAR PRESSED BRONZER  SPF 50
octinoxate, titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31645-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	4 g  in 100 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	21 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Talc (UNII: 7SEV7J4R1U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Dimethicone (UNII: 92RU3N3Y1O)
Genistein (UNII: DH2M523P0H)
Enoxolone (UNII: P540XA09DR)
Alpha Lipoic Acid (UNII: 73Y7P0K73Y)
Tomato (UNII: Z4KHF2C175)
Squalane (UNII: GW89575KF9)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
Ubidecarenone (UNII: EJ27X76M46)
Zinc Stearate (UNII: H92E6QA4FV)
Edetate Disodium (UNII: 7FLD91C86K)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Dehydroacetate (UNII: 8W46YN971G)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferric Oxide Red (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31645-152-02	1 in 1 BOX
1	NDC: 31645-152-01	10.4 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2010

Labeler - Physicians Formula Inc (021261805)

Registrant - Physicians Formula Inc (021261805)