Label: ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20- octinoxate, titanium dioxide, zinc oxide cream

  • NDC Code(s): 10345-903-15, 10345-903-45
  • Packager: LABORATOIRES M&L
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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

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

  • Drug Facts

  • Active ingredients

    Ethylhexyl Methoxicynnamate / Octinoxate 3%
    Titanium dioxide 6,28% 
    Zinc oxide 1.92%

    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 - CI 77492/iron oxides - dipropylene glycol - peg-10 dimethicone - dimethicone - isoeicosane - talc - hexyl laurate - betaine - disteardimonium hectorite - panax ginseng root extract - kigelia africana fruit extract - portulaca oleracea extract - lycyrrhiza glabra (licorice) root extract - dioscorea villosa (wild yam) root extract - equisetum giganteum extract - glycosyl trehalose - palmitic acid - magnesium sulfate - aluminum hydroxide - dimethicone/vinyl dimethicone crosspolymer - acrylates/dimethicone copolymer - hydrogenated starch hydrolysate - stearic acid - methicone - phenoxyethanol - tocopheryl acetate - triethoxycaprylylsilane - parfum/fragrance - ethylhexylglycerin
    - butylene glycol - hexyl cinnamal - citronellol - alpha-isomethyl ionone - linalool - geraniol - eugenol - limonene - CI 77499/iron oxides - CI 77491/iron oxides

  • Questions or comments?

    Call toll free 1-888-975-2162

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20 
    octinoxate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10345-903
    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)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    TALC (UNII: 7SEV7J4R1U)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    BETAINE (UNII: 3SCV180C9W)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    KIGELIA AFRICANA FRUIT (UNII: L4J6XXD1E0)  
    PURSLANE (UNII: M6S840WXG5)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
    BEMISIOSE (UNII: 76B4LOB2YC)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    EUGENOL (UNII: 3T8H1794QW)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10345-903-151 in 1 BOX12/16/2016
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10345-903-451 in 1 BOX12/16/2016
    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 finalpart35212/16/2016
    Labeler - LABORATOIRES M&L (262533623)