Label: AC CARE BEES SHIELD BB BROAD SPECTRUM SPF 35- octinoxate, titanium dioxide, zinc oxide cream

  • NDC Code(s): 42361-151-01
  • Packager: DongSung Pharm 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 November 23, 2020

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  • DESCRIPTION

    a.c.care BEE'S Shield B.B. Cream

    Broad Spectrum SPF 35

    Optimized fusion of Bee Venom, Honey and Royal Jelly Extracts, which are from Honeybees, a.c.care Bee's Shield B.B. Cream naturally covers blemishes, making your skin flawless and glow like honey-glossed. Natural ingredients derived from power and wisdom of honeybee help your skin to relax from stress, giving a perfect match for sensitive skin!

    'Skin-Shielding' multi-functional B.B. Cream for clear skin and a flawless complexion

  • ACTIVE INGREDIENT

    Active Ingredients

    Octinoxate 7%

    Titanium Dioxide 4.41%

    Zinc Oxide 1.96%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    Not only will it help prevent sunburn, it also reduces the risk of skin cancer and early skin aging if used as directed with other sun protection measures. (SPF value of 15 or higher)

  • WARNINGS

    Warnings

    For external use only. Do not use on damaged or broken skin. Discontinue use if signs of irritation or rash appear. Avoid contact with eyes. Wash off immediately with cold water if product comes in contact with eyes. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away. Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum 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. and wear long-sleeved shirts, pants, hats and sunglasses. For use on skin only. Allergy Alert: Contains Bee Venom. Customers with known bee allergies should not this product as bee venom may induce allergic response(s).

  • INSTRUCTIONS FOR USE

    Directions

    At the end of basic skin care regimen, apply liberally on face to cover the entire facial area and lightly go over parts where extra cover-up is needed with detailed perfection. Apply 15 minutes before sun exposure. For added protection, reapply at least every 2 hours, after swimming, towel drying or extended sun exposure. Use a water resistant sunscreen if swimming or sweating.

    Children under 6 months: Ask a doctor.

  • OTHER SAFETY INFORMATION

    Other Information

    Protect this product from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Cyclopentasiloxane, Dimethicone Copolyol, Butylenes Glycol, Talc, Cyclohexasiloxane, Cethyl Ethylhexanoate, Quaternium-18 Bentonite, Dimethicone, Glycerin, Mineral Oil, Arbutin, PEG-10 Glyceryl Triisostearate, Magnesium Sulfate, Magnesium Stearate, Iron Oxides (CI 77492, CI 77491, CI 77499), Methylparaben, Ammonium Glycyrrhizate, Tocopheryl Acetate, Panthenol, Propylparaben, Dimethiconol Stearate, Adenosine, Allantoin, Aluminum Dimyristate, Honey Extract, Hydrolyzed Silk, Sodium Hyaluronate, Portulaca Oleracea Extract, Camellia Japonica Flower Extract, Royal Jelly Extract, Bee Venom

  • Package Image

    Package Image

  • INGREDIENTS AND APPEARANCE
    AC CARE BEES SHIELD BB  BROAD SPECTRUM SPF 35
    octinoxate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42361-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE44.1 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION19.6 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    APIS MELLIFERA VENOM (UNII: 76013O881M)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    BENTOQUATAM (UNII: 7F465U79Q1)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ARBUTIN (UNII: C5INA23HXF)  
    PEG-10 GLYCERYL TRIISOSTEARATE (UNII: 8U46MJI8HO)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ADENOSINE (UNII: K72T3FS567)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PORTULACA OLERACEA LEAF (UNII: 9JW9D9JGHZ)  
    CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)  
    ROYAL JELLY (UNII: L497I37F0C)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HONEY (UNII: Y9H1V576FH)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)  
    TALC (UNII: 7SEV7J4R1U)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42361-151-011 in 1 CARTON04/01/2016
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2016
    Labeler - DongSung Pharm Co., Ltd. (687811661)
    Registrant - Dong Sung World Wide USA, Inc. (784969219)
    Establishment
    NameAddressID/FEIBusiness Operations
    DongSung Pharm Co., Ltd.687811661label(42361-151)
    Establishment
    NameAddressID/FEIBusiness Operations
    Omar Sharif Cosmetic Co., Ltd.689316318manufacture(42361-151)