Label: NATURIUM UV REFLECT ANTIOXIDANT SPF 50- homosalate, octisalate, avobenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

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  • Drug Facts

  • Active Ingredients

    Avobenzone 3.0%

    Homosalate 10.0%

    Octisalate 5.0%

  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    • Shake well before use.
    • Apply liberally and evenly 15 minutes before sun exposure.

    Reapply:

    • After 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours.
    • Children under 6 months: ask a doctor.
    • Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 10:00 a.m. - 2:00 p.m.
    • Wear long sleeved shirts, pants, hats, and sunglasses.
  • Other Information

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

    Aqua/Water/Eau, Isododecane, Polymethyl Methacryate, Butyloctyl Salicylate, Acrylates Copolymer, Saccharomyces Ferment, Aluminum Starch Octenylsuccinate, Butylene Glycol, Polyglyceryl-6 Polyricinoleate, C24-28 Alkyldimethylsiloxy Trimethylsiloxysilicate, Polyglyceryl-2 Dipolyhydroxystearate, Disteardimonium Hectorite, Sodium Chloride, Caesalpinia Spinosa Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Sodium Stearoyl Glutamate, Glycine Soja (Soybean) Oil, Squalane, Raspberry Ketone, Lauroyl Lysine, Caprylyl/Capryl Glucoside, Triethyl Citrate, Polyglyceryl-10 Dioleate, Hydroxyethylcellulose, Octyldodecanol, Tocopherol, Sodium Phytate, Disodium Phosphate, Sodium Phosphate, Sodium Benzoate, Caprylyl Glycol, Propylene Glycol, Citric Acid, Phenoxyethanol.

  • Questions?

    www.naturium.com

  • Product Packaging

    1

  • INGREDIENTS AND APPEARANCE
    NATURIUM UV REFLECT ANTIOXIDANT SPF 50 
    homosalate, octisalate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)  
    SQUALANE (UNII: GW89575KF9)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISODODECANE (UNII: A8289P68Y2)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76354-125-011 in 1 CARTON04/10/2023
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/10/2023
    Labeler - e.l.f. Cosmetics, Inc (093902816)
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