Label: ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR- octinoxate, octisalate, titanium dioxide, zinc oxide cream

  • NDC Code(s): 10345-911-01, 10345-911-05, 10345-911-15, 10345-911-45
  • Packager: LABORATOIRES M&L
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2023

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  • Drug Facts

  • Active ingredients

    Ethylhexyl methoxycinnamate / Octinoxate 6.00%

    Ethylhexyl salicylate / Octisalate 2.00%

    Titanium dioxide 4.33%

    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 - Dipropylene Glycol - Glycerin - Peg- 10 Dimethicone - Methyl Trimethicone - C12- 15 Alkyl Benzoate - Dimethicone - Disteardimonium Hectorite - Magnesium Sulfate - Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer - Centella Asiatica Extract - Mel/Honey Extract - Talc - Dimethicone/Vinyl Dimethicone Crosspolymer -Phenoxyethanol - Ethylhexylglycerin - Trihydroxystearin - Butylene Glycol - Mica - Aluminum Hydroxide - Palmitic Acid - Stearic Acid - Polyester- 1 - Silica Dimethyl Silylate - Tocopheryl Acetate - Methicone - Tocopherol - Parfum/Fragrance - Hexyl Cinnamal - Alpha-Isomethyl Ionone - Linalool - Citronellol - Geraniol - Eugenol - Limonene - Cl 77492/Iron Oxides - Cl77491/Iron Oxides - Cl77499/Iron Oxides

  • Questions or comments?

    Call toll free 1-888-975-2162

  • Package Labeling:

    CCBB1

    CCFF1

    TT11

    LL11

  • INGREDIENTS AND APPEARANCE
    ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR 
    octinoxate, octisalate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10345-911
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE43.3 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)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    TALC (UNII: 7SEV7J4R1U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MICA (UNII: V8A1AW0880)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYESTER-10 (UNII: 212N9O2MMZ)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    EUGENOL (UNII: 3T8H1794QW)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10345-911-151 in 1 BOX07/13/2016
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10345-911-011.5 mL in 1 PACKET; Type 0: Not a Combination Product12/03/2017
    3NDC:10345-911-451 in 1 BOX07/13/2016
    345 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:10345-911-051 in 1 BOX07/01/2018
    45 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/13/2016
    Labeler - LABORATOIRES M&L (262533623)
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