Label: FRESH SUGAR ROSE TINTED LIP TREATMENT SPF 15- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 49817-1988-4, 49817-1988-8 - 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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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
FRESH SUGAR ROSE TINTED LIP TREATMENT SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49817-1988 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) Jojoba Oil (UNII: 724GKU717M) Castor Oil (UNII: D5340Y2I9G) 1-Decanol (UNII: 89V4LX791F) Grape Seed Oil (UNII: 930MLC8XGG) Carnauba Wax (UNII: R12CBM0EIZ) Avocado Oil (UNII: 6VNO72PFC1) Meadowfoam Seed Oil (UNII: 412ZHA4T4Y) FD&C Yellow No. 6 (UNII: H77VEI93A8) Titanium Dioxide (UNII: 15FIX9V2JP) D&C Red No. 7 (UNII: ECW0LZ41X8) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Polyglycerin-3 (UNII: 4A0NCJ6RD6) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) Alpha-Tocopherol (UNII: H4N855PNZ1) Rosa Damascena Flower (UNII: JWB78P295A) Ribes Nigrum Seed Oil (UNII: GKE1188837) Ferric Oxide Red (UNII: 1K09F3G675) Sunflower Oil (UNII: 3W1JG795YI) Propyl Gallate (UNII: 8D4SNN7V92) Ascorbyl Palmitate (UNII: QN83US2B0N) Ricinoleic Acid (UNII: I2D0F69854) Isostearic Acid (UNII: X33R8U0062) Aluminum Oxide (UNII: LMI26O6933) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49817-1988-4 1 in 1 CARTON 1 NDC:49817-1988-8 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 06/01/2009 Labeler - Guerlain (395158322)
