![RE9 ADVANCED PREPWORK (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ARBONNE INTERNATIONAL, LLC]](https://medic.hrt.org//dailymed/images/7ec7d9a8-91f0-4b9e-b096-b0bbeb957a77/re9-01.jpg)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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 and evenly 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
- children under 6 months of age: 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 value 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-sleeved shirts, pants, hats, and sunglasses
- Other information
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Inactive ingredients
water, ethylhexyl palmitate, caprylic/capric triglyceride, cyclopentasiloxane, diisopropyl sebacate, isononyl isononanoate, polyglyceryl-6 polyricinoleate, polymethylsilsesquioxane, glycerin, argania spinosa kernel oil, polyglyceryl-2 isostearate, tocopheryl acetate, silica, caesalpinia spinosa fruit extract, vaccinium vitis-idaea fruit extract, kappaphycus alvarezii extract, terminalia ferdinandiana fruit extract, chlorella vulgaris extract, aloe barbadensis leaf juice powder, raspberry seed oil/tocopheryl succinate aminopropanediol esters, olive oil decyl esters, hydrolyzed pea protein, sea salt, squalene, saccharide isomerate, bisabolol, isopropyl myristate, hydrogenated castor oil, xanthan gum, gluconolactone, calcium gluconate, hydrated silica, tocopherol, sodium chloride, magnesium stearate, disteardimonium hectorite, stearalkonium hectorite, propylene carbonate, polyhydroxystearic acid, bentonite, alumina, isopropyl titanium triisostearate, lactic acid, citric acid, phenoxyethanol, potassium sorbate, sodium benzoate, mica, iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891).
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
-
INGREDIENTS AND APPEARANCE
RE9 ADVANCED PREPWORK
titanium dioxide and zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42508-096 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42508-096-10 1 in 1 CARTON 04/19/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 3 mL Part 2 1 TUBE 3 mL Part 3 1 TUBE 3 mL Part 1 of 3 RE9 ADVANCED PREPWORK CLEANSING POLISH
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR Glycerin (UNII: PDC6A3C0OX) INGR COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) INGR Lauryl Glucoside (UNII: 76LN7P7UCU) INGR Methacrylic Acid - Ethyl Acrylate Copolymer (4500 MPA.S) (UNII: T967IEU43C) INGR Sodium Lauryl Sulfoacetate (UNII: D0Y70F2B9J) INGR Prunus Armeniaca Seed (UNII: 75356789IW) INGR Glyceryl 1-Undecylenate (UNII: B68LJT9544) INGR Xanthan Gum (UNII: TTV12P4NEE) INGR Sunflower Oil (UNII: 3W1JG795YI) INGR Lingonberry (UNII: 0UNK9RZQ7X) INGR Apple (UNII: B423VGH5S9) INGR Passiflora Incarnata Fruit (UNII: SF206I8G4P) INGR Hylocereus Undatus Fruit (UNII: WUG58TD53X) INGR Kakadu Plum (UNII: 0ZQ1D2FDLI) INGR Niacinamide (UNII: 25X51I8RD4) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR Hexylene Glycol (UNII: KEH0A3F75J) INGR Sodium Carbonate (UNII: 45P3261C7T) INGR Sodium Sulfate (UNII: 0YPR65R21J) INGR Gluconolactone (UNII: WQ29KQ9POT) INGR Calcium Gluconate (UNII: SQE6VB453K) INGR Caprylhydroxamic Acid (UNII: UPY805K99W) INGR Sodium Chloride (UNII: 451W47IQ8X) INGR Citric Acid Monohydrate (UNII: 2968PHW8QP) INGR Sodium Hydroxide (UNII: 55X04QC32I) INGR Caprylyl Glycol (UNII: 00YIU5438U) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR Potassium Sorbate (UNII: 1VPU26JZZ4) INGR Sodium Benzoate (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 3 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 04/19/2018 Part 2 of 3 RE9 ADVANCED PREPWORK HYDRATING DEW CREAM
moisturizingProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR Isononyl Isononanoate (UNII: S4V5BS6GCX) INGR Medium-Chain Triglycerides (UNII: C9H2L21V7U) INGR Glycerin (UNII: PDC6A3C0OX) INGR Apple (UNII: B423VGH5S9) INGR Steareth-21 (UNII: 53J3F32P58) INGR Steareth-2 (UNII: V56DFE46J5) INGR Dimethicone (UNII: 92RU3N3Y1O) INGR Cetyl Alcohol (UNII: 936JST6JCN) INGR Stearyl Alcohol (UNII: 2KR89I4H1Y) INGR Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer (52000 MPA.S) (UNII: LZ291VH90H) INGR Xanthan Gum (UNII: TTV12P4NEE) INGR Lingonberry (UNII: 0UNK9RZQ7X) INGR Lentil (UNII: 6O38V6B52O) INGR Clary Sage (UNII: U3HSK5JC0Q) INGR Kakadu Plum (UNII: 0ZQ1D2FDLI) INGR Fig (UNII: TGD87RII2U) INGR Niacinamide (UNII: 25X51I8RD4) INGR Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11) INGR Propanediol (UNII: 5965N8W85T) INGR Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG) INGR Hyaluronate Sodium (UNII: YSE9PPT4TH) INGR Gluconolactone (UNII: WQ29KQ9POT) INGR Calcium Gluconate (UNII: SQE6VB453K) INGR Sodium Carbonate (UNII: 45P3261C7T) INGR Citric Acid Monohydrate (UNII: 2968PHW8QP) INGR Lactic Acid, Dl- (UNII: 3B8D35Y7S4) INGR Sodium Hydroxide (UNII: 55X04QC32I) INGR Sodium Chloride (UNII: 451W47IQ8X) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Potassium Sorbate (UNII: 1VPU26JZZ4) INGR Tert-Butyl Alcohol (UNII: MD83SFE959) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 3 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 04/19/2018 Part 3 of 3 RE9 ADVANCED PREPWORK SOFT FOCUS VEIL BROAD SPECTRUM SPF 30 SUNSCREEN
titanium dioxide and zinc oxide lotionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 2.5 mg in 100 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 7.2 mg in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Ethylhexyl Palmitate (UNII: 2865993309) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Cyclomethicone 5 (UNII: 0THT5PCI0R) Diisopropyl Sebacate (UNII: J8T3X564IH) Isononyl Isononanoate (UNII: S4V5BS6GCX) Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69) Glycerin (UNII: PDC6A3C0OX) Argan Oil (UNII: 4V59G5UW9X) Polyglyceryl-2 Monoisostearate (UNII: 7B8OE71MQC) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Silicon Dioxide (UNII: ETJ7Z6XBU4) Lingonberry (UNII: 0UNK9RZQ7X) Kappaphycus Alvarezii (UNII: T479H08K2O) Kakadu Plum (UNII: 0ZQ1D2FDLI) Chlorella Vulgaris (UNII: RYQ4R60M02) Aloe Vera Leaf (UNII: ZY81Z83H0X) Olive Oil Decyl Esters (UNII: 3AQ222F18X) Sea Salt (UNII: 87GE52P74G) Squalene (UNII: 7QWM220FJH) Saccharide Isomerate (UNII: W8K377W98I) Levomenol (UNII: 24WE03BX2T) Isopropyl Myristate (UNII: 0RE8K4LNJS) Hydrogenated Castor Oil (UNII: ZF94AP8MEY) Xanthan Gum (UNII: TTV12P4NEE) Gluconolactone (UNII: WQ29KQ9POT) Calcium Gluconate (UNII: SQE6VB453K) Hydrated Silica (UNII: Y6O7T4G8P9) Tocopherol (UNII: R0ZB2556P8) Sodium Chloride (UNII: 451W47IQ8X) Magnesium Stearate (UNII: 70097M6I30) Disteardimonium Hectorite (UNII: X687XDK09L) Stearalkonium Hectorite (UNII: OLX698AH5P) Propylene Carbonate (UNII: 8D08K3S51E) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Bentonite (UNII: A3N5ZCN45C) Aluminum Oxide (UNII: LMI26O6933) Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I) Lactic Acid, Dl- (UNII: 3B8D35Y7S4) Anhydrous Citric Acid (UNII: XF417D3PSL) Phenoxyethanol (UNII: HIE492ZZ3T) Potassium Sorbate (UNII: 1VPU26JZZ4) Sodium Benzoate (UNII: OJ245FE5EU) Mica (UNII: V8A1AW0880) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 3 mL in 1 TUBE; 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 04/19/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 04/19/2018 Labeler - Arbonne International, LLC (021541164)
