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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IMCOVERActive Ingredients

Titanium Dioxide, Zinc Oxide, Ethylhexyl Methoxycinnamate

Inactive Ingredients

Cetyl Ethylhexanoate, Cera Alba, Dimethicone, Phenyl Trimethicone, Methyl Hydrogenated Rosinate , Butylene Glycol, Dicaprylate/Dicaprate, Candelilla Cera, Ozokerite, Mica, Nylon-12, Ricinus Communis (Castor) Seed Oil, Methyl Methacrylate crosspolymer, Cyclopentasiloxan, Cyclohexasiloxane, Oleic/Linoleic/Linolenic Polyglycerides, Sorbitan Sesquioleate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Sorbitan Stearate, Sorbitan Olivate, Sucrose Tetrastearate Triacetate , Stearalkonium Hectorite, Ethylhexylglycerin, Caprylyl Glycol, Propylene Carbonate, Tropolone, Triethoxycaprylylsilane, BHT , AQUA, Centella Asiatica Extract, Butylene Glycol, Glycerin, Macadamia Ternifolia Seed Oil, Hydrogenated Lecithin, Ceramide NP, 1,2-Hexanediol, Squalane, Paeonia Lactiflora Root Extract, Lilium Candidum Flower Extract, Magnolia Liliflora Flower Extract, Ipomoea Purpurea Extract, Convallaria Majalis Extract, Rosa Hybrid Flower Extract, Calendula Officinalis Flower Extract, Lavandula Angustifolia Flower Extract, Chamomilla Recutita Flower Extract , Camellia Japonica Flower Extract, Phenoxyethanol , CI 77492, CI 77491, CI 77499, Fragrance

IM COVER BB SUNSTICK 
titanium dioxide, zinc oxide, ethylhexyl methoxycinnamate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72284-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.037 g  in 21 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.585 g  in 21 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.47 g  in 21 g
Inactive Ingredients
Ingredient NameStrength
CONVALLARIA MAJALIS (UNII: QHH4HVF5QE)  
CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
NYLON-12 (UNII: 446U8J075B)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
TROPOLONE (UNII: 7L6DL16P1T)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
SQUALANE (UNII: GW89575KF9)  
IPOMOEA PURPUREA TOP (UNII: XMQ0V9812O)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
MICA (UNII: V8A1AW0880)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)  
WHITE WAX (UNII: 7G1J5DA97F)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
CANDELILLA WAX (UNII: WL0328HX19)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
GLYCERIN (UNII: PDC6A3C0OX)  
MACADAMIA OIL (UNII: 515610SU8C)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ)  
MAGNOLIA LILIIFLORA FLOWER (UNII: SVM28292LH)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CHAMOMILE (UNII: FGL3685T2X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CERAMIDE NP (UNII: 4370DF050B)  
Product Characteristics
Color    Score    
ShapeROUNDSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72284-0003-11 in 1 BOX04/24/2019
121 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 finalpart35204/24/2019
Labeler - Normalest Co., Ltd. (694812877)
Registrant - Normalest Co., Ltd. (694812877)
Establishment
NameAddressID/FEIBusiness Operations
Normalest Co., Ltd.694812877manufacture(72284-0003)

Revised: 4/2019
Document Id: 871eb1a2-c232-5daf-e053-2991aa0acb81
Set id: 871eb1a2-c231-5daf-e053-2991aa0acb81
Version: 1
Effective Time: 20190422
 
Normalest Co., Ltd.