BAREMINERALS PREP STEP MINERAL SHIELD BROAD SPECTRUM SPF 50 DAILY PREP- zinc oxide and titanium dioxide lotion

bareMinerals Prep Step Mineral Shield Broad Spectrum SPF 50 Daily Prep by

Drug Labeling and Warnings

bareMinerals Prep Step Mineral Shield Broad Spectrum SPF 50 Daily Prep 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 INGREDIENT

Active ingredient(s)	Purpose
Zinc oxide 23.8%	Sunscreen
Titanium dioxide 4.1%	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

coconut alkanes, caprylyl caprylate/caprate, water, squalane, adipic acid/neopentyl glycol crosspolymer, polyglyceryl-2 diisostearate, silica, glycerin, propanediol, sorbitan sesquiisostearate, isostearic acid, coco-caprylate/caprate, triethoxycaprylylsilane, gentiana urnula flower extract, moringa oleifera seed extract, butylene glycol, magnesium hydroxide, sodium citrate, citric acid, polyester-1, silica dimethyl silylate, disodium phosphate, phenoxyethanol. may contain: mica, titanium dioxide, iron oxides.

Other information

Protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-795-4747

SPL UNCLASSIFIED SECTION

Dist. by Bare Escentuals Beauty, Inc., SF, CA 94105 USA

PRINCIPAL DISPLAY PANEL - 40 mL Bottle Carton

bareMinerals®
PREP STEP™

MINERAL SHIELD

BROAD SPECTRUM
SPF 50

DAILY PREP LOTION

INGREDIENTS AND APPEARANCE

BAREMINERALS PREP STEP MINERAL SHIELD BROAD SPECTRUM SPF 50 DAILY PREP 
zinc oxide and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-761
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	238 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	41 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
coconut alkanes (UNII: 1E5KJY107T)
caprylyl caprylate/caprate (UNII: 22MCG4RSMR)
water (UNII: 059QF0KO0R)
squalene (UNII: 7QWM220FJH)
polyglyceryl-2 diisostearate (UNII: DG195GP57P)
silicon dioxide (UNII: ETJ7Z6XBU4)
glycerin (UNII: PDC6A3C0OX)
propanediol (UNII: 5965N8W85T)
isostearic acid (UNII: X33R8U0062)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
triethoxycaprylylsilane (UNII: LDC331P08E)
gentiana urnula flower (UNII: 2RIZ3HY23X)
moringa oleifera seed (UNII: TIX5482832)
butylene glycol (UNII: 3XUS85K0RA)
magnesium hydroxide (UNII: NBZ3QY004S)
sodium citrate (UNII: 1Q73Q2JULR)
citric acid monohydrate (UNII: 2968PHW8QP)
silica dimethyl silylate (UNII: EU2PSP0G0W)
sodium phosphate, dibasic, anhydrous (UNII: 22ADO53M6F)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-761-01	1 in 1 CARTON
1		40 mL in 1 BOTTLE; 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	04/01/2015

Labeler - Bare Escentuals Beauty, Inc. (087008363)