Label: VEIL FLUID MAKEUP IVORY SPF 15- octinoxate, octisalate, oxybenzone emulsion

  • 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 December 5, 2016

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  • ACTIVE INGREDIENT

    Active Ingredients               Purpose
    Octinoxate  7.5%                          Sunscreen
    Octisalate  4.0%                           Sunscreen
    Oxybenzone 3.0%                         Sunscreen

    Enter section text here

  • INDICATIONS & USAGE

    Uses
    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging cause by the sun.
  • WARNINGS

    For external use only.

    Do not use on damage or broken skin.

    When using this product keep out of eyes.  If contact occurs, rinse thoroughly with water.

    Stop Use and ask a doctor if irritation or rash develops.

    Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INSTRUCTIONS FOR USE

    Directions

    • SHAKE WELL, and apply to moisturized or primed skin with fingertips or Hourglass Foundation Brush.
    • 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 sun 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 INGREDIENT

    Inactive Ingredients  CETEARYL ETHYLHEXANOATE, CETYL PEG/PPG 10/1 DIMETHICONE, CYCLOPENTASILOXANE, DIMETHICONE, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL BEHENATE, GLYCERYL DIBEHENATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSS-POLYMER, HEXYL LAURATE, HYDROLYZED WHEAT PROTEIN, HYDOXYPROPYL CYCLODEXTRIN, ISODODECANE, ISOEICOSANE, MACROCYSTIC PYRIFERA EXTRACT, MAGNESIUM SULFATE, PALMITOYL TRIPEPTIDE-38, PENTAERYTHRITYL TETRAISOSTEARATE, PHENOXYETHANOL, PHENYL TRIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, POTASSIUM SORBATE, PROPYLENE CARBONATE, PVP, QUATERNIUM-90 BENTONITE, SILICA, SODIUM BENZOATE, TOCOPHERYL ACETATE, TRIBEHENIN, TRIETHOXYLCAPRYLYLSILANE, WATER. MAY CONTAIN (+/-): IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), TITANIUM DIOXIDE (CI 77891).

  • OTHER SAFETY INFORMATION

    Other Information

    Protect this product from excessive heat and direct sun.

  • QUESTIONS

    Questions or comments?

    CALL TOLL FREE 855-201-4529

  • HOW SUPPLIED

    DIST. BY KINGDOM ANIMALIA, LLC.  VENICE, CA 90291  USA
    HOURGLASS COSMETICS, UK LTD, LONDON WC1D 3JA
    MADE IN USA   PRODUCT NOT TESTED ON ANIMALS

  • PRINCIPAL DISPLAY PANEL

    VeilFluidMU

  • INGREDIENTS AND APPEARANCE
    VEIL FLUID MAKEUP IVORY  SPF 15
    octinoxate, octisalate, oxybenzone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42627-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.0 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BIOTIN (UNII: 6SO6U10H04)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISODODECANE (UNII: A8289P68Y2)  
    QUATERNIUM-91 (UNII: 00J8H295NB)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42627-202-021 in 1 CARTON06/01/2012
    1NDC:42627-202-0150 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 finalpart35206/01/2012
    Labeler - Kingdom Animalia, LLC. DBA Hourglass Cosmetics (004924553)
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