Label: NOTE BB CONCEALER 01- octinoxate cream

  • NDC Code(s): 70474-015-01
  • Packager: ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 16, 2024

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

  • Drug Facts

  • Active ingredient

    Octinoxate 0.6%

    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

    • 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

    Cyclopentasiloxane, Water (Aqua), PEG-10 Dimethicone, Butylene Glycol, Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Disteardimonium Hectorite, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Alcohol, Triethoxycaprylylsilane, Glycerin, Tocopheryl Acetate, Trimethylsiloxysilicate, Bran (Triticum vulgare) Extract, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Glycol, Ethylhexylglycerin, Silica, BHT, Bitter Orange(Citrus aurantium) Fruit Extract, Grapefruit (Citrus paradisi) Fruit Extract, Lecithin, Sorbitol, Sodium Ascorbate, Sunflower (Helianthus annus) Seed Oil, Tocopherol, Sodium Hydroxide. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

  • Package Labeling:

    Outer Label1inner Label1

  • INGREDIENTS AND APPEARANCE
    NOTE BB CONCEALER 01 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70474-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GRAPEFRUIT (UNII: O82C39RR8C)  
    WHEAT (UNII: 4J2I0SN84Y)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALCOHOL (UNII: 3K9958V90M)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BITTER ORANGE (UNII: DQD16J2B5O)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70474-015-011 in 1 CARTON01/29/2023
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/29/2023
    Labeler - ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI (502657469)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI502657469manufacture(70474-015)