Label: IM COVER BB SUNSTICK- titanium dioxide, zinc oxide, ethylhexyl methoxycinnamate stick
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Contains inactivated NDC Code(s)
NDC Code(s): 72284-0015-2 - Packager: Normalest Co., Ltd.
- 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 October 22, 2019
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INGREDIENTS AND APPEARANCE
IM COVER BB SUNSTICK
titanium dioxide, zinc oxide, ethylhexyl methoxycinnamate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72284-0015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.13 g in 15 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.455 g in 15 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.05 g in 15 g Inactive Ingredients Ingredient Name Strength STEARALKONIUM HECTORITE (UNII: OLX698AH5P) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SORBITAN OLIVATE (UNII: MDL271E3GR) RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) WHITE WAX (UNII: 7G1J5DA97F) LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) MAGNOLIA LILIIFLORA FLOWER (UNII: SVM28292LH) CHAMOMILE (UNII: FGL3685T2X) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CERAMIDE NP (UNII: 4370DF050B) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TROPOLONE (UNII: 7L6DL16P1T) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CENTELLA ASIATICA (UNII: 7M867G6T1U) SQUALANE (UNII: GW89575KF9) IPOMOEA PURPUREA TOP (UNII: XMQ0V9812O) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) CANDELILLA WAX (UNII: WL0328HX19) FERRIC OXIDE RED (UNII: 1K09F3G675) CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF) DIMETHICONE (UNII: 92RU3N3Y1O) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) MICA (UNII: V8A1AW0880) MACADAMIA OIL (UNII: 515610SU8C) NYLON-12 (UNII: 446U8J075B) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PROPYLENE CARBONATE (UNII: 8D08K3S51E) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) Product Characteristics Color Score Shape ROUND Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72284-0015-2 1 in 1 BOX 10/22/2019 1 15 g in 1 CONTAINER; 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 10/22/2019 Labeler - Normalest Co., Ltd. (694812877) Registrant - Normalest Co., Ltd. (694812877) Establishment Name Address ID/FEI Business Operations Normalest Co., Ltd. 694812877 manufacture(72284-0015)
