HEALTHY WEAR TINTED MOISTURIZER SPF 50- octinoxate, octocrylene, titanium dioxide, zinc oxide lotion

Healthy Wear Tinted Moisturizer by

Drug Labeling and Warnings

Healthy Wear Tinted Moisturizer 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 7.5%, Octocrylene 5%, Titanium Dioxide 8.5%, Zinc Oxide 2.94%
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.
  

WHEN USING

When using this product

• Keep out of eyes.
• Rinse with water to remove.
  

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.

STOP USE

Stop use and ask doctor if

• Rash or irritation develops and lasts
  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTHY WEAR TINTED MOISTURIZER   SPF 50
octinoxate, octocrylene, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31645-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	5 g  in 100 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	8.5 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	2.94 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Butylene Glycol (UNII: 3XUS85K0RA)
Alcohol (UNII: 3K9958V90M)
C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)
Lecithin, Soybean (UNII: 1DI56QDM62)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Edetate Disodium (UNII: 7FLD91C86K)
Gelatin (UNII: 2G86QN327L)
Genistein (UNII: DH2M523P0H)
Alpha Lipoic Acid (UNII: 73Y7P0K73Y)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Palmitic Acid (UNII: 2V16EO95H1)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Propylene Carbonate (UNII: 8D08K3S51E)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Squalane (UNII: GW89575KF9)
Sucrose (UNII: C151H8M554)
Alpha-Tocopherol (UNII: H4N855PNZ1)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Trolamine (UNII: 9O3K93S3TK)
Ubidecarenone (UNII: EJ27X76M46)
Xanthan Gum (UNII: TTV12P4NEE)
Starch, Corn (UNII: O8232NY3SJ)
Ethylene Brassylate (UNII: 9A87HC7ROD)
Phenoxyethanol (UNII: HIE492ZZ3T)
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: 31645-150-02	1 in 1 BOX
1	NDC: 31645-150-01	33 g in 1 BOTTLE, PUMP

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)

Establishment
Name	Address	ID/FEI	Business Operations
Physicians Formula Inc.		825048945	manufacture(31645-150)