Label: MISSHA M PERFECT COVER BB NO 31- zinc oxide, titanium dioxide, octinoxate cream

  • NDC Code(s): 13733-181-01, 13733-181-02, 13733-181-03
  • 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: Octinoxate 7.5%, Zinc Oxide 7%, Titanium Dioxide 4.19%

  • 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 ocurs

  • 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 INGREDIENT

    Water, Cyclopentasiloxane, Propylene Glycol, Caprylic/Capric Triglyceride, PEG-10 Dimethicone, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Mineral Oil, Polyethylene, Talc, Phenyl Trimethicone, Beeswax (Cera Alba), Sodium Chloride, Ferric Oxide Yellow, Methylparaben, Dimethicone, Ferric Oxide Red, Propylparaben, Rosa Canina Fruit Oil, Squalane, Macadamia Ternifolia Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Cyclotetrasiloxane, Ferrosoferric oxide, Disodium EDTA, Adenosine, Algae Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ceramide NP, Butylene Glycol, Fagus Sylvatica Bud Extract, Hydrolyzed collagen, Caprylyl Glycol, Benzyl Alcohol, 1,2-Hexanediol, Caprylhydroxamic Acid, Tocopherol, Benzoic Acid, Sodium Hyaluronate, Phenoxyethanol, Tropolone, Fragrance (Parfum), Butylphenyl Methylpropional, Benzyl Salicylate, Hydroxycitronellal, Alpha-Isomethyl Ionone, Hexyl Cinnamal, Linalool, Citronellol, Limonene

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    BB31_50ML

  • INGREDIENTS AND APPEARANCE
    MISSHA M PERFECT COVER BB NO 31 
    zinc oxide, titanium dioxide, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-181
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.07 g  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.0419 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MACADAMIA OIL (UNII: 515610SU8C)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SQUALANE (UNII: GW89575KF9)  
    ARBUTIN (UNII: C5INA23HXF)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ABRONIA VILLOSA LEAF (UNII: A138B5260A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LAMINARIA HYPERBOREA (UNII: NXA595GQ1K)  
    ROSEMARY (UNII: IJ67X351P9)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    JOJOBA OIL (UNII: 724GKU717M)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ADENOSINE (UNII: K72T3FS567)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TRIS(TRIMETHYLSILOXY)PHENYLSILANE (UNII: S3QI0ZXT5X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13733-181-0150 g in 1 TUBE; Type 0: Not a Combination Product10/01/2019
    2NDC:13733-181-0220 g in 1 TUBE; Type 0: Not a Combination Product10/01/2019
    3NDC:13733-181-031 g in 1 PACKET; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2019
    Labeler - Able C&C Co., Ltd. (689540284)
    Registrant - Able C&C Co., Ltd. (689540284)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hanacos Co., Ltd.690177857manufacture(13733-181)