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HALO HD FOUNDATION BROAD SPECTRUM SPF 15 OIL FREE (SMASHBOX BEAUTY COSMETICS, INC)

Available Formats

Dosage Form Package Information Links
LIQUID 1 BOTTLE in 1 CARTON (10348-010-01) > 30 mL in 1 BOTTLE Label Information

Complete HALO HD FOUNDATION BROAD SPECTRUM SPF 15 OIL FREE Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredients

    Octinoxate 4.90%

    Titanium Dioxide 2.90%


  • Purpose

    Sunscreen


  • Use

    helps prevent sunburn


  • 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

    For sunscreen use:

    • apply liberally and evenly 15 minutes before sun exposure
    • reapply at least every two 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 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

  • Inactive Ingredients

    Water\Aqua\Eau, Isododecane, Cyclopentasiloxane, Dimethicone, Butylene Glycol, Polymethyl Methacrylate, Trioctyldodecyl Citrate, Polysilicone-11, Coco-Caprylate/Caprate, PEG/PPG-18/18 Dimethicone, Polyglyceryl-4 Isostearate, Sodium Hyaluronate, Ascorbyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Quaternium-90 Bentonite, Dimethicone Silylate, Magnesium Aluminum Silicate, Alumina, Silica, Propylene Carbonate, Sodium Chloride, Caprylyl Glycol, Hexylene Glycol, Stearic Acid, Palmitic Acid, C12-16 Alcohols, Hydrogenated Lecithin, Disodium EDTA, Phenoxyethanol, [+/- Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)] <ILN39852>


  • Other information

    • protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    smashbox

    LIQUID
    HALO

    HD FOUNDATION

    BROAD SPECTRUM
    SPF 15
    OIL-FREE

    1 fl. oz./30 ml e

    Principal Display Panel - 30 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    HALO HD FOUNDATION BROAD SPECTRUM SPF 15 OIL FREE 
    octinoxate and titanium dioxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10348-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.05635 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.03335 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Isododecane (UNII: A8289P68Y2)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Trioctyldodecyl Citrate (UNII: 35X8CT063R)  
    Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)  
    PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
    Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Hexyl Laurate (UNII: 4CG9F9W01Q)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Propylene Carbonate (UNII: 8D08K3S51E)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Palmitic Acid (UNII: 2V16EO95H1)  
    C12-16 Alcohols (UNII: S4827SZE3L)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Mica (UNII: V8A1AW0880)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10348-010-01 1 in 1 CARTON
    1 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 04/01/2013
    Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC K.K. 712808195 RELABEL(10348-010) , REPACK(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(10348-010) , RELABEL(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 943871157 MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 959338336 MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 949264774 MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(10348-010)
    Establishment
    Name Address ID/FEI Business Operations
    Pennsylvania Logistics Center 078364654 REPACK(10348-010) , RELABEL(10348-010)