Label: FRESH SUGAR PLUM TINTED LIP TREATMENT SPF 15- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 49817-1989-4, 49817-1989-9 - Packager: Guerlain
- 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 31, 2010
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INGREDIENTS AND APPEARANCE
FRESH SUGAR PLUM TINTED LIP TREATMENT SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49817-1989 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.49 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 2.0 g in 100 g Inactive Ingredients Ingredient Name Strength White Wax (UNII: 7G1J5DA97F) Castor Oil (UNII: D5340Y2I9G) Jojoba Oil (UNII: 724GKU717M) 1-Decanol (UNII: 89V4LX791F) Grape Seed Oil (UNII: 930MLC8XGG) Carnauba Wax (UNII: R12CBM0EIZ) Avocado Oil (UNII: 6VNO72PFC1) Meadowfoam Seed Oil (UNII: 412ZHA4T4Y) Titanium Dioxide (UNII: 15FIX9V2JP) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Polyglycerin-3 (UNII: 4A0NCJ6RD6) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) Alpha-Tocopherol (UNII: H4N855PNZ1) Ribes Nigrum Seed Oil (UNII: GKE1188837) Sunflower Oil (UNII: 3W1JG795YI) Propyl Gallate (UNII: 8D4SNN7V92) Ascorbyl Palmitate (UNII: QN83US2B0N) FD&C Yellow No. 6 (UNII: H77VEI93A8) D&C Red No. 7 (UNII: ECW0LZ41X8) Ferrosoferric Oxide (UNII: XM0M87F357) Glycyrrhizin, Ammoniated (UNII: 3VRD35U26C) FD&C Yellow No. 5 (UNII: I753WB2F1M) Vanillin (UNII: CHI530446X) Passiflora Incarnata Seed Oil (UNII: S0SU5AC95J) Isostearic Acid (UNII: X33R8U0062) Aluminum Oxide (UNII: LMI26O6933) Ricinoleic Acid (UNII: I2D0F69854) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49817-1989-4 1 in 1 CARTON 1 NDC:49817-1989-9 4.3 g in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2010 Labeler - Guerlain (395158322)
