Label: MISSHA M PERFECT COVER BB NO 23- zinc oxide, titanium dioxide, octinoxate cream

  • NDC Code(s): 13733-160-01, 13733-160-02
  • Packager: Able C&C 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

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Active Ingredients: Zinc Oxide 7%, Titanium Dioxide 4.19%, Ethylhexyl Methoxycinnamate 7.5%

  • Purpose

    Sunscreen

  • Uses

    helps prevent sunburn

    if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Do not use

    on damaged or broken skin

  • When using this product

    keep out of eyes. Rinse with water to Remove.

  • Stop use and ask a doctor

    if rash occurs

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating

    Sun protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary use a sunscreen with SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
  • Other Information

    protect the product in this container from excessive heat and direct sun.

  • Questions or comments?

    visit www.misshaus.com or call 1-888-985-9887(Ext 104)

  • Inactive Ingredients

    Inactive Ingredients: Water (Aqua), Cyclomethicone, Propylene Glycol, Caprylic/Capric Triglyceride, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Mineral Oil, Glycerin, Polyethylene, Talc, Phenyl Trimethicone, Beeswax (Cera Alba), Iron Oxides (CI 77492), Sodium Chloride, Iron Oxides (CI 77491 ), Iron Oxides (CI 77499), Methylparaben, Dimethicone, Propylparaben, Rosa Canina Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Hydrolyzed Collagen, Macadamia Ternifolia Seed Oil, Disodium EDTA, Adenosine, Caviar Extract, Algae Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Sodium Hyaluronate, Fagus Sylvatica Bud Extract, Ceramide 3, Fragrance (Parfum), Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Butylphenyl Methylpropional, Benzyl Salicylate, Hydroxycitronellal, Alpha-Isomethyl Ionone, Hexyl Cinnamal, Linalool, Citronellol

  • MISSHA M Perfect Cover BB Cream No 23

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MISSHA M PERFECT COVER BB NO 23 
    zinc oxide, titanium dioxide, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.5 g  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.09 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SQUALANE (UNII: GW89575KF9)  
    TRIS(TRIMETHYLSILOXY)PHENYLSILANE (UNII: S3QI0ZXT5X)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    LAMINARIA HYPERBOREA (UNII: NXA595GQ1K)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ROSEMARY (UNII: IJ67X351P9)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    ABRONIA VILLOSA LEAF (UNII: A138B5260A)  
    ARBUTIN (UNII: C5INA23HXF)  
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ADENOSINE (UNII: K72T3FS567)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13733-160-0150 mL in 1 CARTON; Type 0: Not a Combination Product07/01/2016
    2NDC:13733-160-021 mL in 1 PACKET; Type 0: Not a Combination Product07/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2015
    Labeler - Able C&C Co., Ltd. (689540284)
    Registrant - Able C&C Co., Ltd. (689540284)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANACOS CO., LTD.690177857manufacture(13733-160)