Label: ERBORIAN - BB CREME AU GINSENG DORE SPF 20- octinoxate, titanium dioxide, zinc oxide cream

  • NDC Code(s): 10345-901-15, 10345-901-45
  • Packager: LABORATOIRES M&L
  • 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 December 31, 2020

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  • Drug Facts

  • Active ingredients

    Ethylhexyl methoxycinnamate / Octinoxate 3.00%....….......Sunscreen
    Titanium dioxide 6.28%......Sunscreen
    Zinc oxide 1.92%................Sunscreen

    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
  • Warnings

    ​For external use only

    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.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    For sunscreen use:

    • 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,  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.
    • Wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: Ask a doctor
  • Other information

    • Protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    Aqua/water - cyclomethicone - glycerin - talc - dipropylene glycolpeg-10 dimethicone - dimethicone - hexyl laurate - CI 77492/iron oxides - disteardimonium hectorite - betaine - isoeicosane - panax ginseng root extract - portulaca oleracea extract - glycyrrhiza glabra (licorice) root extract - dioscorea villosa (wild yam) root extract - kigelia africana fruit extract - equisetum giganteum extract - hydrogenated starch hydrolysate - ethylhexylglycerin - tocopheryl acetate - glycosyl trehalose - magnesium sulfate - aluminum hydroxide - palmitic acid - stearic
    acid - phenoxyethanol - butylene glycol - dimethicone/vinyl dimethicone crosspolymer - methicone - acrylates/dimethicone copolymer -  parfum/fragrance - hexyl cinnamal - alpha-isomethyl ionone - linalool - citronellol - geraniol - eugenol - limonene - CI 77491/iron oxide

  • Questions or comments?

    Call toll free 1-888-975-2162

  • Product Label

    GinsengDore

  • INGREDIENTS AND APPEARANCE
    ERBORIAN - BB CREME AU GINSENG DORE SPF 20 
    octinoxate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10345-901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE62.8 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION19.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BETAINE (UNII: 3SCV180C9W)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    PURSLANE (UNII: M6S840WXG5)  
    LICORICE (UNII: 61ZBX54883)  
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
    KIGELIA AFRICANA FRUIT (UNII: L4J6XXD1E0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    EUGENOL (UNII: 3T8H1794QW)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10345-901-151 in 1 BOX02/06/2015
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10345-901-451 in 1 BOX02/06/2015
    245 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/06/2015
    Labeler - LABORATOIRES M&L (262533623)
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