Label: NARS RADIANCE PRIMER BROAD SPECTRUM SPF 35 SUNSCREEN- octisalate, octocrylene, avobenzone, homosalate lotion

  • NDC Code(s): 68577-159-01
  • Packager: COSMAX USA, CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 25, 2023

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

  • ACTIVE INGREDIENT

    Active Ingredients

    Homosalate 6%

    Octisalate 5%

    Octocrylene 1.6%

    Avobenzone 2%

  • PURPOSE

    Purpose

    Sunscreen

  • USES

    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 cause by the sun
  • Warnings

    Warnings

    For extenal use only

    Do not useon damaged or broken skin

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor ifrash occurs

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

  • DIRECTIONS

    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 INGREDIENT

    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

    Other information

    • Protect the product in this container from excessive heat and direct sun
  • QUESTIONS or COMMENTS

    Questions or comments?

    Call toll free 1-888-788-NARS

  • PRINCIPAL DISPLAY PANEL

    Packaging

    Primary Package

  • INGREDIENTS AND APPEARANCE
    NARS RADIANCE PRIMER BROAD SPECTRUM SPF 35 SUNSCREEN 
    octisalate, octocrylene, avobenzone, homosalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-159
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 100 mg
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 mg  in 100 mg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.6 mg  in 100 mg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ISODODECANE (UNII: A8289P68Y2)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-159-011 in 1 CARTON06/01/2023
    130 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2023
    Labeler - COSMAX USA, CORPORATION (010990210)
    Registrant - COSMAX USA, CORPORATION (010990210)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX USA. CORPORATION010990210manufacture(68577-159)