BAREMINERALS DAILY DEFENSE BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide lotion

bareMinerals Daily Defense Broad Spectrum SPF 30 by

Drug Labeling and Warnings

bareMinerals Daily Defense Broad Spectrum SPF 30 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
Titanium dioxide 3%	Sunscreen
Zinc oxide 15.3%	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/aqua, caprylic/capric triglyceride, squalane, butylene glycol, isopropyl myristate, SD alcohol 40-B (alcohol denat.), dimethicone, glycerin, PPG-3 dipivalate, PEG-100 hydrogenated castor oil, silica, isostearic acid, triethoxycaprylylsilane, hydrated silica, phenoxyethanol, sorbitan sesquiisostearate, dimethylacrylamide/sodium acryloyldimethyltaurate crosspolymer, cellulose gum, succinoglycan, sodium metaphosphate, PEG/PPG-14/7 dimethyl ether, citric acid, disodium EDTA, alcohol, distearyldimonium chloride, soil minerals, sodium citrate, rosmarinus officinalis (rosemary) leaf oil, thymus serpillum extract, citrus aurantium dulcis (orange) oil, tocopherol, sodium acetylated hyaluronate, rosa canina fruit extract, betula platyphylla japonica bark extract, sophora angustifolia root extract, 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 - 25 mL Tube Carton

bareMinerals

DAILY DEFENSE
BROAD SPECTRUM
SPF 30

25 ml / 0.84 fl. oz.

INGREDIENTS AND APPEARANCE

BAREMINERALS DAILY DEFENSE BROAD SPECTRUM SPF 30 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-724
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	30 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1530 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SQUALANE (UNII: GW89575KF9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOSTEARIC ACID (UNII: X33R8U0062)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ROSEMARY OIL (UNII: 8LGU7VM393)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
ORANGE OIL (UNII: AKN3KSD11B)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
BETULA PLATYPHYLLA BARK (UNII: ZF70YKN0YO)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-724-01	1 in 1 CARTON
1		25 mL in 1 TUBE

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)