Label: BAREMINERALS DAILY DEFENSE BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 98132-724-01 - Packager: Bare Escentuals Beauty, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 12, 2014
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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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
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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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton
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INGREDIENTS AND APPEARANCE
BAREMINERALS DAILY DEFENSE BROAD SPECTRUM SPF 30
titanium dioxide and zinc oxide lotionProduct 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)