Label: ILLUSION TINTED MOISTURIZER BROAD SPECTRUM WARM IVORY SPF 15- octinoxate, octisalate, titanium dioxide emulsion

  • NDC Code(s): 42627-261-01, 42627-261-02
  • Packager: Kingdom Animalia, LLC DBA Hourglass Cosmetics
  • 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 October 31, 2022

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  • Active Ingredients

    Octinoxate  7.0%

    Octisalate 4.0%

    Titanium Dioxide 4.0%

    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 product is 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

    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 of 15 or higher and other skin protection measures including:

    • Limit time in the sun, especially from 10 a.m. – 2 p.m.
    • Wear long-sleeve shirts, pants, hats and sunglasses.

    Children under 6 months: Ask a doctor

  • Inactive Ingredients

    ALUMINA, BUTYLENE GLYCOL, CALCIUM CARBONATE, CAPRYLYL GLYCOL, CETYL PEG/PPG 10/1 DIMETHICONE, ETHYLHEXYL PALMITATE, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL BEHENATE, GLYCERYL DIBEHENATE, GOSSYPIUM HERBACEUM(COTTON), HEXYL LAURATE, HEXYLENE GLYCOL, HYDROGENATED POLYISOBUTENE, LYCIUM BARBARUM FRUIT EXTRACT, MAGNESIUM SULFATE, MICA, MICROCRYSTALLINE WAX, PEG-10 DIMETHICONE, PENTAERYTHRITYL, TETRASISOSTERATE, PHENOXYETHANOL, POLYETHYLACRYLATE, POLYGLYCERYL-3 BEESWAX, POLYGLYCERYL-3 POLYRICINOLEATE, POLYGLYCERYL-4 ISOSTEARATE, POTASSIUM SORBATE, PROPYLENE CARBONATE, QUATERNIUM-90 BENTONITE, SILICA, SILICA DIMETHYL SILYLATE, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM HYALURONATE, STEARIC ACID, TREBEHENIN, TRIETHOXYLCAPRYLYLSILANE, WATER. MAY CONTAIN (+/-): IRON OXIDES (CI77491), IRON OXIDES (CI77492), IRON OXIDES (CI77499), TITANIUM DIOXIDE (CI77891).

  • Other information

    Protect this product from excessive heat and direct sun.

  • Questions or Comments?

    Call toll free 855-201-4529

  • PRINCIPAL DISPLAY PANEL

    ILLUC

  • INGREDIENTS AND APPEARANCE
    ILLUSION TINTED MOISTURIZER BROAD SPECTRUM WARM IVORY   SPF 15
    octinoxate, octisalate, titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42627-261
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GOSSYPIUM HERBACEUM WHOLE (UNII: 9DK7DJK0D6)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MICA (UNII: V8A1AW0880)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42627-261-021 in 1 CARTON07/01/2014
    1NDC:42627-261-0130 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 finalpart35207/01/2014
    Labeler - Kingdom Animalia, LLC DBA Hourglass Cosmetics (004924553)
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