Label: CARECELLA VELVET COVER BB CREAM NO 25- octyl methoxycinnamate, titanium dioxide, zinc oxide cream

  • NDC Code(s): 69422-1005-1, 69422-1005-2
  • Packager: General Bio Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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

  • ACTIVE INGREDIENT

    Octyl Methoxycinnamate (7.5%)

    Titanium Dioxide (4.2%)
    Zinc Oxide (7%)

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps to prevent sunburn

  • WARNINGS

    For external use only.

  • DO NOT USE

    • if you are allergic to any of the ingredients
    • on damaged or broken skin
  • WHEN USING

    • keep out of eyes. Rinse with water to remove.
  • STOP USE

    • rash or irritation develops and lasts.
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    • Apply liberally on cleansed skin 15 minutes prior to sun exposure.
    • Reapply as needed or after towel drying, swimming or sweating.
    • At least every 2 hours
    • Children under 6 months: Ask a doctor.
  • OTHER SAFETY INFORMATION

    • Store in a cool dry place away from direct sunlight.
    • (You may add “high sun protection product” for SPF protection 30 or above)
    • “Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.”
  • INACTIVE INGREDIENT

    Water, Cyclopentasiloxane, Ethylhexyl Methoxycinnamate, Zinc Oxide, Titanium Dioxide, Butylene Glycol, Titanium Dioxide, Aluminum Hydroxide, Triethoxycaprylylsilane, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexyl Palmitate, Sorbitan Sesquioleate, Caprylic/Capric, Triglyceride, Arbutin, Cyclopentasiloxane, Dimethicone, PEG-10 Dimethicone Crosspolymer, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol, Hydroxyacetophenone, Caprylyl Glycol, CI 77492, 1,2-Hexanediol, Sodium Chloride, Beeswax, CI 77491, Magnesium Aluminum Silicate, Disteardimonium Hectorite, CI 77499, Ozokerite, Lavandula Angustifolia (Lavender) Oil, Linalool, Adenosine, Allantoin, Panthenol, Chamomilla, Recutita (Matricaria) Flower Extract, Gentiana Lutea Root Extract, Artemisia Absinthium Extract, Portulaca Oleracea Extract, Acer Saccharum (Sugar Maple) Extract.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CARECELLA VELVET COVER BB CREAM NO 25 
    octyl methoxycinnamate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69422-1005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69422-1005-21 in 1 BOX10/26/2020
    1NDC:69422-1005-150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/26/2020
    Labeler - General Bio Co., Ltd. (695273863)
    Registrant - General Bio Co., Ltd. (695273863)
    Establishment
    NameAddressID/FEIBusiness Operations
    General Bio Co., Ltd.695273863manufacture(69422-1005)