BAREMINERALS ADVANCED PROTECTION SPF 20 MOISTURIZER COMBINATION SKIN- titanium dioxide and zinc oxide 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 INGREDIENT

Active ingredients	Purpose
Titanium dioxide 5%	Sunscreen
Zinc oxide 3%	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

Acacia Dealbata Flower/Stem Extract, Alumina, Aluminum Stearate, Aspalathus Linearis Extract, Aspalathus Linearis Leaf Extract, Bambusa Arundinacea Stem Powder, Camellia Oleifera Leaf Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Ethylhexanoate, Chamomilla Recutita (Matracaria) Flower Extract, Chondrus Crispus (Carrageenan) Extract, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Coco-Caprylate/Caprate, Coffea Arabica (Coffee) Seed Extract, Cymbopogon Martini Oil, Dicaprylyl Ether, Ectoin, Ethylhexylglycerin, Geraniol, Glycerin, Glyceryl Isostearate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glycine Soja (Soybean) Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Jojoba Esters, Laminaria Ochroleuca Extract, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Limonene, Linalool, Methylisothiazolinone, Phenoxyethanol, Phyllanthus Emblica Fruit Extract, Polyhydroxystearic Acid, Propanediol, Prunus Armeniaca (Apricot) Kernel Oil, Pyrus Malus (Apple) Fruit Extract, Silica, Sodium Benzoate, Sodium Citrate, Sodium Stearoyl Glutamate, Soil Minerals, Spiraea Ulmaria Extract, Tocopherol, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Water, Xanthan Gum.

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 Carton

bareMinerals

ADVANCED
PROTECTION
SPF 20
MOISTURIZER

COMBINATION
SKIN

50 mL / 1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

BAREMINERALS ADVANCED PROTECTION SPF 20 MOISTURIZER   COMBINATION SKIN
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-720
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	50 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACACIA DEALBATA FLOWER (UNII: 4025U039M3)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
BAMBUSA BAMBOS STEM (UNII: NRA4497HC5)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CHAMOMILE (UNII: FGL3685T2X)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BERGAMOT OIL (UNII: 39W1PKE3JI)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
PALMAROSA OIL (UNII: 0J3G3O53ST)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
ECTOINE (UNII: 7GXZ3858RY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GERANIOL (UNII: L837108USY)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
SOYBEAN OIL (UNII: 241ATL177A)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LAVANDIN OIL (UNII: 9RES347CKG)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
PROPANEDIOL (UNII: 5965N8W85T)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
APPLE (UNII: B423VGH5S9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-720-01	1 in 1 CARTON
1		50 mL in 1 BOTTLE

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)