Label: OCTINOXATE lotion

  • 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 August 27, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 5%

    Titanium Dioxide 10%

  • 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 the eyes. Rinse with water to remove.

    Stop use and ask a doctor if skin 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
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months of age: Ask a doctor

    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
  • Other information

    • protect this product from excessive heat and direct sun
  • Inactive ingredients

    Aqua (Water/Eau), Ethylhexyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Trimellitate, Silica, Cyclopentasiloxane, Caprylic/Capric Triglyceride, HDI/Trimethylol Hexyllactone Crosspolymer, Butylene Glycol, Glycerin, Polyglyceryl-3 Diisostearate, Cyclohexasiloxane, Octyldodecanol, Octyldecyl Xyloside, PEG-30 Dipolyhydroxystearate, Silica Dimethyl Silylate, Phenoxyethanol, Hydroxyethylacrylate/Sodium Acryloydimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Caprylyl Glycol, Ethylhexyl Glycerin, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Polymethylsilsesquioxane, Dimethicone, Retinyl Palmitate (Vitamin A), Triethoxycaprylylsilane, Camellia Oleifera (Green Tea) Leaf Extract, Diamond Powder, (+/-):Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

  • Questions or comments?

    Call: 1.800.232.0398 M-F 9am-6pm MST

  • Principal Display Panel - 30 mL Carton Label

    LUXE

    LIQUID FOUNDATION

    BROAD SPECTRUM SPF 18

    ANTI-AGING

    DIAMOND POWDER

    TECHNOLOGY

    glo·minerals

    30 mL / 1 fl. oz.

    Principal Display Panel - 30 mL Carton Label
  • INGREDIENTS AND APPEARANCE
    OCTINOXATE 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60541-8407
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Neopentyl Glycol Dicaprylate/Dicaprate (UNII: VLW429K27K)  
    Tridecyl Trimellitate (UNII: FY36J270ES)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Peg-30 Dipolyhydroxystearate (UNII: 9713Q0S7FO)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Silica Dimethyl Silylate (UNII: EU2PSP0G0W)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.S At 1%) (UNII: 86FQE96TZ4)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Camellia Oleifera Leaf (UNII: 5077EL0C60)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60541-8407-41 in 1 BOX
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2013
    Labeler - Hayden Caleel LLC (011367468)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hayden Caleel LLC011367468MANUFACTURE(60541-8407)
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