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

Drug Label Information

Updated December 9, 2023

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  • 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  ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
  • 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
    • 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: Sun Protection Measures.
    • 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 DrugM02012/16/2016
    Labeler - LABORATOIRES M&L (262533623)
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