Label: MISSHA M PERFECT COVER BB CREAM SPF42 (NO. 25)- zinc oxide, titanium dioxide, octinoxate cream

  • NDC Code(s): 13733-165-01, 13733-165-02
  • 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 Ingredients

    Octinoxate 7.5%, Active Ingredients: Zinc Oxide 7.0%, Titanium Dioxide 4.20%

  • 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.

  • Inactive Ingredients

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

  • Questions or Comments?

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

  • MISSHA M Perfect Cover BB Cream SPF42 (No. 25)

    MISSHA M Perfect Cover BB Cream SPF42 (No. 25)

  • INGREDIENTS AND APPEARANCE
    MISSHA M PERFECT COVER BB CREAM SPF42 (NO. 25) 
    zinc oxide, titanium dioxide, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.099 g  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.5 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TALC (UNII: 7SEV7J4R1U)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    ARBUTIN (UNII: C5INA23HXF)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TRIS(TRIMETHYLSILOXY)PHENYLSILANE (UNII: S3QI0ZXT5X)  
    ABRONIA VILLOSA LEAF (UNII: A138B5260A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    LAMINARIA HYPERBOREA (UNII: NXA595GQ1K)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SQUALANE (UNII: GW89575KF9)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ADENOSINE (UNII: K72T3FS567)  
    ROSEMARY (UNII: IJ67X351P9)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13733-165-0150 mL in 1 CARTON; Type 0: Not a Combination Product12/14/2017
    2NDC:13733-165-021 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 finalpart35212/14/2017
    Labeler - Able C&C Co., Ltd. (689540284)
    Registrant - Able C&C Co., Ltd. (689540284)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANACOS CO., LTD.690177857manufacture(13733-165)