MINERAL WEAR- titanium dioxide, zinc oxide powder

Mineral Wear by

Drug Labeling and Warnings

Mineral Wear by is a Otc medication manufactured, distributed, or labeled by Mei Shual Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                         Purpose

Titanium Dioxide 6.0%, Zinc Oxide 4.2% ....................... Sunscreen

PURPOSE

Uses

• Helps prevent Sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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.

INDICATIONS & USAGE

Physicians Formula

Mineral Wear

Talc-Free Mineral Face Powder

SPF 16 Broad Spectrum Sunscreen

Minimalist formula helps reduce irritation & breakout.

Net Wt. 0.3 oz / 9g

For extra sensitive or breakout-prone skin!

Recommended as an effective broad spectrum sunscreen

HYPOALLERGENIC

FRAGRANCE FREE

GLUTEN FREE

NON-COMEDOGENIC

DERMATOLOGIST APPROVED

WARNINGS

Warnings For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs.

DOSAGE & ADMINISTRATION

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: Ask a doctor

Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 am - 2pm
• wear long-sleeve pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive Ingredients:

mica, squalane, silica, lauroyl lysine, boron nitride, kaolin, retinyl palmitate, tocopheryl acetate, dehydroacetic acid. may contain: titanium dioxide, iron oxides, chromium hydroxide green.

OTHER SAFETY INFORMATION

Other Information: protect this product from excessive heat and direct sun

Questions or comments?  Call toll-free 1-800-227-0333

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL WEAR 
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69184-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
SQUALANE (UNII: GW89575KF9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LAUROYL LYSINE (UNII: 113171Q70B)
BORON NITRIDE (UNII: 2U4T60A6YD)
KAOLIN (UNII: 24H4NWX5CO)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69184-002-01	9 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/08/2014

Labeler - Mei Shual Cosmetics Co., Ltd. (656375912)

Establishment
Name	Address	ID/FEI	Business Operations
Mei Shual Cosmetics Co., Ltd.		656375912	manufacture(69184-002)