BAREMINERALS- titanium dioxide and zinc oxide powder BAREMINERALS- titanium dioxide and zinc oxide powder

BareMinerals by

Drug Labeling and Warnings

BareMinerals by is a Otc medication manufactured, distributed, or labeled by Orveon Global US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 25%	Sunscreen
Zinc Oxide 10%	Sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection

Warnings

For external use only

When using this product

• Keep out of eyes
• Rinse with water to remove

Stop use and ask a doctor if

• Rash or irritation develops and lasts

• Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply evenly before sun exposure as needed

Other Information

• Store at room temperature (59°-88°F)
• Adverse Event Reporting: 71 Stevenson St., 22 Fl., SF, CA 94105. Attn: OTC

Inactive Ingredients

Silica, Zea Mays (Corn) Starch, Corn Starch Modified, Zinc Stearate, Magnesium Stearate May Contain: Iron Oxides.

SPL UNCLASSIFIED SECTION

Dist. by Bare Escentuals Beauty, Inc., San Francisco, CA 94105, USA

PRINCIPAL DISPLAY PANEL - 6 g Jar Label (Original)

bareMinerals
ORIGINAL SPF 25 Mineral Veil

original SPF 25
mineral veil

6 g / 0.21 Oz.

PRINCIPAL DISPLAY PANEL - 6 g Jar Label (Tinted)

bareMinerals
TINTED SPF 25 Mineral Veil

tinted SPF 25
mineral veil

6 g / 0.21 Oz.

Dist. by Bare Escentuals Beauty, Inc., San Francisco, CA 94105, USA
London W10 3QB

INGREDIENTS AND APPEARANCE

BAREMINERALS   MINERAL VEIL
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	25 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Starch, Corn (UNII: O8232NY3SJ)
Zinc Stearate (UNII: H92E6QA4FV)
Magnesium Stearate (UNII: 70097M6I30)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-159-02	1.5 g in 1 JAR
2	NDC: 98132-159-03	6 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	07/30/2009

BAREMINERALS   TINTED MINERAL VEIL
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	25 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Starch, Corn (UNII: O8232NY3SJ)
Zinc Stearate (UNII: H92E6QA4FV)
Magnesium Stearate (UNII: 70097M6I30)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-160-02	1.5 g in 1 JAR
2	NDC: 98132-160-03	6 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	07/30/2009

Labeler - Bare Escentuals Beauty Inc. (087008363)