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

  • 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 April 29, 2022

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

  • Drug Facts

  • Active ingredients

    Octisalate 4%

    Titanium dioxide 3.54%

    Zinc oxide 2.94%

    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 - DIMETHICONE - CI 77492/IRON OXIDES - CAPRYLIC/CAPRIC TRIGLYCERIDE - GLYCERIN - BUTYLOCTYL SALICYLATE - CI 77491/IRON OXIDES - HEXYL LAURATE - DISILOXANE - CI 77499/IRON OXIDES - PEG-10 DIMETHICONE - DISTEARDIMONIUM HECTORITE - BETAINE - BUTYLENE GLYCOL - PENTYLENE GLYCOL - MAGNESIUM SULFATE - CI 77891/TITANIUM DIOXIDE - PANAX GINSENG ROOT EXTRACT - GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT - KIGELIA AFRICANA FRUIT EXTRACT - DIOSCOREA VILLOSA (WILD YAM) ROOT EXTRACT - EQUISETUM GIGANTEUM EXTRACT - CETYL PEG/PPG-10/1 DIMETHICONE - DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER - TRIETHOXYCAPRYLYLSILANE - SYNTHETIC FLUORPHLOGOPITE - STEARIC ACID - ALUMINA - GLYCERYL CAPRYLATE - PALMITIC ACID - CAPRYLYL GLYCOL - ALUMINUM HYDROXIDE - PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE - TIN OXIDE - ALCOHOL - ETHYLHEXYLGLYCERIN - PARFUM/FRAGRANCE - HEXYL CINNAMAL - ALPHA-ISOMETHYL IONONE - LINALOOL - CITRONELLOL – GERANIOL

  • Questions or comments?

    Call toll free 1-888-975-2162

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ERBORIAN BB CREME AU GINSENG CHOCOLATE SPF 20 
    octisalate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10345-904
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35.4 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION29.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BETAINE (UNII: 3SCV180C9W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    KIGELIA AFRICANA FRUIT (UNII: L4J6XXD1E0)  
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10345-904-451 in 1 BOX05/01/2022
    145 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 finalpart35205/01/2022
    Labeler - LABORATOIRES M&L (262533623)