BAREMINERALS ADVANCED PROTECTION SPF 20 MOISTURIZER NORMAL TO DRY SKIN- titanium dioxide lotion

bareMinerals Advanced Protection SPF 20 Moisturizer by

Drug Labeling and Warnings

bareMinerals Advanced Protection SPF 20 Moisturizer 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 6%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

• Skin cancer/skin aging alert: spending time in the sun increases your risk of skin cancer and early aging
• This product has been shown only to help prevent sunburn, not skin cancer or early aging
• 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

• 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

Inactive ingredients

Aluminum Hydroxide, Anthemis Nobilis Flower Oil, Ascorbic Acid, Benzyl Benzoate, Butylene Glycol, Caprylic/Capric Triglyceride, Cetyl Hydroxyethylcellulose, Cetyl PEG/PPG-10/1 Dimethicone, Citronellol, Coumarin, Dicaprylyl Carbonate, Disteardimonium Hectorite, Epilobium Angustifolium Flower/Leaf/Stem Extract, Ethylhexylglycerin, Eugenol, Geraniol, Glycerin, Glycine Soja (Soybean) Oil, Isostearic Acid, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Lecithin, Limonene, Linalool, Phenoxyethanol, Phytoecdysteroids, Polyglyceryl-2 Diisostearate, Polymethyl Methacrylate, Polymethylsilsesquioxane, Potassium Sorbate, Propanediol, Retinyl Palmitate, Sinorhizobium Meliloti Ferment Filtrate, Sodium Benzoate, Sodium Metabisulfite, Soil Minerals, Stearic Acid, Tocopherol, Tocopheryl Acetate, Triethylhexanoin, Trisodium EDTA, Water, Zizyphus Jujuba Seed Extract.

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 - 50 mL Bottle Box

bareMinerals

ADVANCED
PROTECTION
SPF 20
MOISTURIZER

NORMAL TO DRY
SKIN

50 mL / 1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

BAREMINERALS ADVANCED PROTECTION SPF 20 MOISTURIZER  NORMAL TO DRY SKIN
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-722
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BENZYL BENZOATE (UNII: N863NB338G)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
COUMARIN (UNII: A4VZ22K1WT)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUGENOL (UNII: 3T8H1794QW)
GERANIOL (UNII: L837108USY)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
ISOSTEARIC ACID (UNII: X33R8U0062)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LAVANDIN OIL (UNII: 9RES347CKG)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANEDIOL (UNII: 5965N8W85T)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
EDETATE TRISODIUM (UNII: 420IP921MB)
WATER (UNII: 059QF0KO0R)
JUJUBE SEED (UNII: I51YGQ1Q2L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-722-01	1 in 1 BOX	12/31/2013
1		50 mL in 1 BOTTLE, PUMP; 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	12/31/2013

Labeler - Bare Escentuals Beauty, Inc. (087008363)