Label: SHISEIDO SUN PROTECTION LIP TREATMENT- octinoxate and titanium dioxide lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 52686-642-20 - Packager: SHISEIDO AMERICA 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 December 13, 2018
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
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Inactive Ingredients
TRIETHYLHEXANOIN, POLYGLYCERYL-2 TRIISOSTEARATE, TRIISOSTEARIN, HYDROGENATED POLYISOBUTENE, POLYETHYLENE, PEG/PPG-36/41 DIMETHYL ETHER, MICROCRYSTALLINE WAX, STEARYL GLYCYRRHETINATE, GLUTATHIONE, ZINC MYRISTATE, THIOTAURINE, SODIUM ACETYLATED HYALURONATE, ALUMINUM HYDROXIDE, TOCOPHEROL, DIISOSTEARYL MALATE, SODIUM MAGNESIUM SILICATE, GLYCERIN, BHT, FRAGRANCE,
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- PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO SUN PROTECTION LIP TREATMENT
octinoxate and titanium dioxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-642 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 296 mg in 4 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 180 mg in 4 g Inactive Ingredients Ingredient Name Strength TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) TRIISOSTEARIN (UNII: 71503RH8KG) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) GLUTATHIONE (UNII: GAN16C9B8O) ZINC MYRISTATE (UNII: K09A9E2GGO) THIOTAURINE (UNII: NQZ2D7AO62) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-642-20 1 in 1 CARTON 10/01/2012 1 4 g in 1 CARTRIDGE; 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 10/01/2012 Labeler - SHISEIDO AMERICA INC. (782677132) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(52686-642) , analysis(52686-642)