IM COVER BB SUNSTICK- titanium dioxide, zinc oxide, ethylhexyl methoxycinnamate stick 
Normalest 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.

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IMCOVERBB

IM COVER BB SUNSTICK 
titanium dioxide, zinc oxide, ethylhexyl methoxycinnamate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72284-0015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.13 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.455 g  in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeROUNDSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72284-0015-21 in 1 BOX10/22/2019
115 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/22/2019
Labeler - Normalest Co., Ltd. (694812877)
Registrant - Normalest Co., Ltd. (694812877)
Establishment
NameAddressID/FEIBusiness Operations
Normalest Co., Ltd.694812877manufacture(72284-0015)

Revised: 10/2019
Document Id: 957f4ce0-271c-1f13-e053-2995a90a0af9
Set id: 957f4ce0-271b-1f13-e053-2995a90a0af9
Version: 1
Effective Time: 20191022
 
Normalest Co., Ltd.