BAREMINERALS BAREPRO MADE-2-FIT PERFORMANCE WEAR FOUNDATION BROAD SPECTRUM SPF 15- titanium dioxide liquid

bareMinerals BarePRO Made-2-Fit Performance Wear Foundation Broad Spectrum SPF 15 by

Drug Labeling and Warnings

bareMinerals BarePRO Made-2-Fit Performance Wear Foundation Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Bare Escentuals Beauty, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide 3.32%

Purpose

Sunscreen

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

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.

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

Directions

For sunscreen use:

• 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 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

water, cyclopentasiloxane, trimethylsiloxysilicate, butylene glycol, silica, peg-10 dimethicone, bis-butyldimethicone polyglyceryl-3, bambusa arundinacea stem extract, sodium glutamate, disteardimonium hectorite, sorbitan sesquiisostearate, hydrogenated lecithin, methicone, papain, aluminum hydroxide, stearic acid, 1,2-hexanediol, caprylyl glycol, carbomer, algin, tocopherol, sodium dehydroacetate, phenoxyethanol. may contain (+/-): titanium dioxide, iron oxides.

Other information

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-795-4747

SPL UNCLASSIFIED SECTION

Dist. by bareMinerals, New York, NY 10022, USA

PRINCIPAL DISPLAY PANEL - 30 mL Tip Card

bareMinerals®

BAREPRO®

PERFORMANCE WEAR LIQUID FOUNDATION SPF 15
24 HOUR WEAR FULL COVERAGE SKIN IMPROVING

MEET YOUR
PERFECT MATCH

CUSTOMIZED BY
MATCH Co

WE WOULD LOVE TO SEE YOUR PERFECT MATCH
SHARE AND TAG — #MADE2FIT

INGREDIENTS AND APPEARANCE

BAREMINERALS BAREPRO MADE-2-FIT PERFORMANCE WEAR FOUNDATION BROAD SPECTRUM SPF 15 
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	33.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Butylene Glycol (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BAMBUSA BAMBOS STEM (UNII: NRA4497HC5)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
Disteardimonium Hectorite (UNII: X687XDK09L)
Sorbitan Sesquiisostearate (UNII: VU97D01BF9)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
METHICONE (20 CST) (UNII: 6777U11MKT)
Papain (UNII: A236A06Y32)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Stearic Acid (UNII: 4ELV7Z65AP)
1,2-Hexanediol (UNII: TR046Y3K1G)
Caprylyl Glycol (UNII: 00YIU5438U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
Tocopherol (UNII: R0ZB2556P8)
Sodium Dehydroacetate (UNII: 8W46YN971G)
Phenoxyethanol (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-253-30	1 in 1 BOX	01/01/2019
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2019

Labeler - Bare Escentuals Beauty, Inc. (087008363)