Label: PURE TRANSFORMATION SHEER CLEAR- titanium dioxide and zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 98132-190-03 - 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 September 6, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
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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.
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 10am to 2 pm, wear long-sleeve shirts, pants, hats, and sunglasses.
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Inactive Ingredients
Boron nitride, glycerin, methylcellulose, maltodextrin, ascorbic acid, illite, trimyrstintin, betaine, phylantus embilica frut extract, sodium hyaluronate, hydrogenated lecithin, aloe barbensis leaf extract, retintyl palmitate, aluminum dimyristate, triethoxycaprylsilane, cyclopia intermedia leaf extract, cameria sinensis leaf extract, ectoin, tocopheryl acetate, triticum vulgare (wheat germ extract), disodium stearoyl glutamate, ferulic acid, litchi chinesis fruit extract, oryza sativa (rice) extract, disodium EDTA, rosmarinus officinalis (rosemary) extract, tetrahydrobisdemthoxydiferuloylmethane, dipotassium glycyrrhizinate, aspalathus linearis leaf extract. May contain: mica. bismuth oxychloride, titanium dioxide, iron oxides.
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 8g Jar Label
bareMinerals
PURE TRANSFORMATION
DAY TREATMENT
BROAD SPECTRUM SPF 20
with ActiveSoil ComplexCLEAR
ACTIVE INGREDIENT(S): TITANIUM DIOXIDE 19%, ZINC OXIDE 5%
See box for complete drug facts information.
WARNING: For external use only. Keep out of reach of
children. If swallowed get medical help or contact
a poison control center right away.69508
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INGREDIENTS AND APPEARANCE
PURE TRANSFORMATION SHEER CLEAR
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:98132-190 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 19 g in 100 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 5 g in 100 g Inactive Ingredients Ingredient Name Strength boron nitride (UNII: 2U4T60A6YD) glycerin (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) magnesium silicate (UNII: 9B9691B2N9) maltodextrin (UNII: 7CVR7L4A2D) silicon dioxide (UNII: ETJ7Z6XBU4) ascorbic acid (UNII: PQ6CK8PD0R) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) TRIMYRISTIN (UNII: 18L31PSR28) betaine (UNII: 3SCV180C9W) PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576) hyaluronate sodium (UNII: YSE9PPT4TH) ALOE (UNII: V5VD430YW9) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALUMINUM DIMYRISTATE (UNII: J2KA067N9O) triethoxycaprylylsilane (UNII: LDC331P08E) CYCLOPIA INTERMEDIA LEAF (UNII: 29UXG2GG8O) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ectoine (UNII: 7GXZ3858RY) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) WHEAT GERM (UNII: YR3G369F5A) disodium stearoyl glutamate (UNII: 45ASM2L11M) ferulic acid (UNII: AVM951ZWST) LITCHI FRUIT (UNII: Y5P61KP51E) rice germ (UNII: 7N2B70SFEZ) Edetate Disodium (UNII: 7FLD91C86K) rosemary (UNII: IJ67X351P9) TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE (UNII: 973IBV8W7I) glycyrrhizinate dipotassium (UNII: CA2Y0FE3FX) aspalathus linearis leaf (UNII: H7UGK1GJCU) mica (UNII: V8A1AW0880) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:98132-190-03 8 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/30/2013 Labeler - Bare Escentuals Beauty Inc. (087008363)