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CLE DE PEAU BEAUTE SMOOTHING BASE for LINES- Titanium Dioxide Cream SHISEIDO CO., LTD

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CLE DE PEAU BEAUTE SMOOTHING BASE for LINES- Titanium Dioxide Cream SHISEIDO CO., LTD CLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES- titanium dioxide cream SHISEIDO CO., LTD. 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. ---------- CLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES Drug Facts Active ingredient TITANIUM DIOXIDE 9.9% Purpose 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 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 children under 6 months: Ask a doctor Inactive Ingredients WATER • CYCLOMETHICONE • GLYCERIN • DIMETHICONE • POLYMETHYL METHACRYLATE • DIPROPYLENE GLYCOL • PEG-10 DIMETHICONE • XYLITOL • BUTYLENE GLYCOL • ERYTHRITOL • PEG-150 • ALUMINUM HYDROXIDE • ALUMINUM DISTEARATE • CETYL ETHYLHEXANOATE • BARIUM SULFATE • DISTEARDIMONIUM HECTORITE • OLEA EUROPAEA (OLIVE) FRUIT OIL • PHENOXYETHANOL • TRIMETHYLSILOXYSILICATE • ISOSTEARIC ACID • TRISODIUM EDTA • FRAGRANCE • IRON OXIDES • TOCOPHEROL • SYNTHETIC FLUORPHLOGOPITE • ALCOHOL • MICA • TALC • SODIUM ACETYLATED HYALURONATE • ROSA ROXBURGHII FRUIT EXTRACT • TRIETHOXYCAPRYLYLSILANE • CAMELLIA SINENSIS LEAF EXTRACT • TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE • PRUNUS SPECIOSA LEAF EXTRACT • DIMETHICONE/METHICONE COPOLYMER • TITANIUM DIOXIDE Other information protect this product in this container from excessive heat and direct sun. Questions or comments? Call toll free 1-800-906-7503 Manufactured by SHISEIDO CO., LTD. 7-5-5 GINZA TOKYO PRINCIPAL DISPLAY PANEL - 34 mL Tube Carton clé de peau BEAUTÉ smoothing base for lines BROAD SPECTRUM SPF 26 SUNSCREEN 34mL NET WT. 1.3 OZ. CLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES titanium dioxide cream Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:526 8 5-19 2 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP) Titanium dio xide 39 6 0 mg in 40 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 0 59 QF0 KO0 R) CYCLO METHICO NE (UNII: NMQ3479 9 4Z) GLYCERIN (UNII: PDC6 A3C0 OX) DIMETHICO NE (UNII: 9 2RU3N3Y1O) DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 ) PEG-10 DIMETHICO NE (6 0 0 CST) (UNII: 8 PR7V1SVM0 ) XYLITO L (UNII: VCQ0 0 6 KQ1E) BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA) ERYTHRITO L (UNII: RA9 6 B9 54X6 ) PO LYETHYLENE GLYCO L 7 0 0 0 (UNII: Q0 JET6 5GEL) ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 ) ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI) CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4) BARIUM SULFATE (UNII: 25BB7EKE2E) O LIVE O IL (UNII: 6 UYK2W1W1E) PHENO XYETHANO L (UNII: HIE49 2ZZ3T) TRIMETHYLSILO XYSILICATE (M/Q 0 .6 6 ) (UNII: 50 41RX6 3GN) ISO STEARIC ACID (UNII: X33R8 U0 0 6 2) EDETATE TRISO DIUM (UNII: 420 IP9 21MB) FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75) FERRIC O XIDE YELLO W (UNII: EX438 O2MRT) .ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1) ALCO HO L (UNII: 3K9 9 58 V9 0 M) MICA (UNII: V8 A1AW0 8 8 0 ) TALC (UNII: 7SEV7J4R1U) RO SA RO XBURGHII FRUIT (UNII: CVT1AA8 7FF) TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E) GREEN TEA LEAF (UNII: W2ZU1RY8 B0 ) PRUNUS SPECIO SA LEAF (UNII: Q71D9 0 0 FVU) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:526 8 5-19 2-6 0 1 in 1 CARTON 1 40 g in 1 TUBE Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC MONOGRAPH NOT FINAL part352 0 9 /0 1/20 0 8 Labeler - SHISEIDO CO., LT D. (690536453) Establishment Name Addre ss ID/FEI Busine ss Ope rations SHISEIDO CO., LTD. 6 9 558 9 38 2 MANUFACTURE(526 8 5-19 2) , ANALYSIS(526 8 5-19 2) Revised: 4/2012 SHISEIDO CO., LTD..
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