Label: NARS RADIANCE PRIMER- avobenzone, homosalate, octisalate, and octocrylene cream

  • NDC Code(s): 13734-158-60, 13734-158-61
  • Packager: NARS 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 November 26, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 2%
    Homosalate 6%
    Octisalate 5%
    Octocrylene 1.6%}

  • 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

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • 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 ingredients

    Water ∙ Caprylyl Methicone ∙ Dipropylene Glycol ∙ Propanediol ∙ Dimethicone ∙ Butyloctyl Salicylate ∙ Lactobacillus Ferment ∙ Isododecane ∙ Ammonium Acryloyldimethyltaurate/VP Copolymer ∙ Trisiloxane ∙ Polysorbate 60 ∙ Trimethylsiloxysilicate ∙ Dextrin Palmitate ∙ Phenoxyethanol ∙ C14-22 Alcohols ∙ Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer ∙ Hydrolyzed Wheat Protein/PVP Crosspolymer ∙ Panthenol ∙ Fragrance ∙ Evodia Rutaecarpa Fruit Extract ∙ Dibutyl Ethylhexanoyl Glutamide ∙ Dibutyl Lauroyl Glutamide ∙ Disodium EDTA ∙ C12-20 Alkyl Glucoside ∙ Dipotassium Glycyrrhizate ∙ Tocopheryl Acetate ∙ Sodium Hyaluronate ∙ Butylene Glycol ∙ Pentylene Glycol ∙ Tin Oxide ∙ Potassium Sorbate ∙ Hydroxyphenyl Propamidobenzoic Acid ∙ Ethylhexylglycerin ∙ Ascorbyl Palmitate ∙ Mica ∙ Titanium Dioxide ∙ Red 4 ∙ Yellow 5 ∙

  • Other information

    • protect this product in this container from excessive heat and direct sun
  • Questions or comments?

    Call toll free 1-888-788-NARS

  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

    NARS

    RADIANCE PRIMER
    BROAD SPECTRUM
    SPF 35 SUNSCREEN

    NET WT.
    1 Oz. 30 mL

    PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    NARS RADIANCE PRIMER 
    avobenzone, homosalate, octisalate, and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13734-158
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE602.4 mg  in 30 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE1807.2 mg  in 30 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1506 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE481.9 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MICA (UNII: V8A1AW0880)  
    LACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ISODODECANE (UNII: A8289P68Y2)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)  
    DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)  
    DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13734-158-601 in 1 CARTON12/01/2016
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:13734-158-611 mL in 1 PACKET; Type 0: Not a Combination Product12/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/01/2016
    Labeler - NARS Cosmetics (837363571)