Label: JUST ENOUGH SPF 15 TINTED MOISTURIZER TAN IS BEAUTIFUL- octinoxate, titanium dioxide, octisalate 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 February 16, 2018

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  • Drug Facts

  • Active ingredients

    Ethylhexyl Methoxycinnamate (5.5%)

    Titanium Dioxide (Nano) 2.7%

    Ethylhexyl Salicylate 3.0%

    Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early sking aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

  • Warnings

    For Exteranl 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 occur.

    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
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • Inacitive Ingredients:

    Water (Aqua), Ethylhexyl Methoxycinnamate, Cetearyl Alcohol, Ethylhexyl Salicylate, Titanium Dioxide, Peg-40 Castor Oil, Cyclopentasiloxane, Xylitylglucoside, Polyglyceryl-4 Isostearate, Hydrogenated Polyisobutene, Magnesium Aluminum Silicate, Cetyl Peg/Ppg-10/1 Dimethicone, Hexyl Laurate, Anhydroxylitol, Tribehenin, Caprylyl Glycol, Xylitol, Xanthan Gum, Hydorxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Galactoarabinan, GLucose, Triethoxycaprylylsilane, Squalane, Aleurites Moluccana (Kukui) Seed Oil, Flavor (Aroma), Vaccinium Angustifolium (Blueberry) Fruit Extract, Cocos Nucifera (Coconut) Oil, Glycerin, Tetrasodium Edta, Polysorbate 60, Camellia Sinensis Leaf (Green Tea) Extract, Bht, Sorbitan Isostearate, Hibiscus Sabdariffa Flower Extract, Tocopherol, Potassium Sorbate. MAY CONTAIN (+/-): Iron Oxides (CI 77491), Iran Oxides (CI 77492), Iron Oxides (CI 77499), Titanium Dioxide (CI 77891).

  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    JUST ENOUGH SPF 15 TINTED MOISTURIZER  TAN IS BEAUTIFUL
    octinoxate, titanium dioxide, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72112-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE27 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SQUALANE (UNII: GW89575KF9)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72112-011-011 in 1 CARTON03/01/2018
    130 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 finalpart35203/01/2018
    Labeler - Bona Fide Beauty Lab PS LLC (064526749)
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