Label: ISNTREE ONION NEWPAIR SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene cream

  • NDC Code(s): 81100-102-01, 81100-102-02
  • Packager: ISNTREE Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 27, 2024

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

  • Active ingredients

    Avobenzone 2.7 %
    Homosalate 9 %
    Octinoxate 6.8 %
    Octisalate 4.5 %
    Octocrylene 4 %

  • Purpose

    sunscreen

  • Uses


    • helps prevent sunburn • higher SPF gives more sunburn protection
    • 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 skin or broken skin.

  • When using this product

    • keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if

    •rash or irritation develops and lasts.

  • Keep out of reach of children

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

  • Directions

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

  • Other information

    ■ protect this product from excessive heat and
    direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and
    using sunscreens may reduce the risks of skin aging, skin cancer, and other
    harmful effects of the sun.

  • Inactive ingredients

    Water, Butyloctyl Salicylate, Butylene Glycol, Acrylates Copolymer, Niacinamide, Polymethylsilsesquioxane, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Glycerin, Pentylene Glycol, Caprylyl Methicone, Cetyl Alcohol, Dicaprylyl Carbonate, Glyceryl Stearate, Tromethamine, Poly C10-30 Alkyl Acrylate, Silica, Coco-Caprylate/Caprate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Trisiloxane, Polyacrylate Crosspolymer-6, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Allium Cepa (Onion) Bulb Extract, Ethylhexylglycerin, Kaolin, Adenosine, Polyhydroxystearic Acid, Xanthan Gum, Triethoxycaprylylsilane, Alumina, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Tocopherol, Allantoin, Panthenol, Houttuynia Cordata Extract, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Polyglyceryl-10 Diisostearate, Glycoproteins, Menadione, Ultramarines(CI 77007), Titanium Dioxide(CI 77891)

  • PRINCIPAL DISPLAY PANEL

    ONION NEWPAIR SUNSCREEN 10 ML

  • INGREDIENTS AND APPEARANCE
    ISNTREE ONION NEWPAIR SUNSCREEN 
    avobenzone, homosalate, octinoxate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81100-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.9 g  in 10 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.68 g  in 10 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.45 g  in 10 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.4 g  in 10 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.27 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    C20-22 ALCOHOLS (UNII: O4M0347C6A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    ONION (UNII: 492225Q21H)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    ADENOSINE (UNII: K72T3FS567)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MENADIONE (UNII: 723JX6CXY5)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81100-102-021 in 1 BOX03/27/2024
    1NDC:81100-102-0110 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/27/2024
    Labeler - ISNTREE Inc. (689043012)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co.,LTD. Gwanjeong 2 factory963271750manufacture(81100-102)