Label: MISSHA M PERFECT COVER BB SPF42 NO29- octinoxate, zinc oxide, titanium dioxide cream

  • NDC Code(s): 13733-245-01, 13733-245-02
  • 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

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  • 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.

  • 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 againg. To decrease this risk, regularly use a sunscreen with SPF value of 15 or higher and other sun protection measures including:

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

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

  • Inactive Ingredient

    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, Phenyl Trimethicone, Beeswax (Cera Alba), Sodium Chloride, Sodium Chloride, Sodium Chloride, Sodium Chloride, Sodium Chloride

  • Questions of comments?

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

  • MISSHA M PERFECT Cover B.B Cream SPF42 No 29 50ML

    MisshaMPerfectCoverBBNo29.50ML

  • INGREDIENTS AND APPEARANCE
    MISSHA M PERFECT COVER BB SPF42 NO29 
    octinoxate, zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-245
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.042 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.07 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ARBUTIN (UNII: C5INA23HXF)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TRIS(TRIMETHYLSILOXY)PHENYLSILANE (UNII: S3QI0ZXT5X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13733-245-0150 g in 1 TUBE; Type 0: Not a Combination Product10/01/2016
    2NDC:13733-245-021 g in 1 PACKET; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2016
    Labeler - Able C&C Co., Ltd. (689540284)
    Registrant - Able C&C Co., Ltd. (689540284)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANACOS CO., LTD.690177857manufacture(13733-245)
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