Label: OARS AND ALPS SPF 50 HYDRATING ANTIOXIDANT SUNSCREENSPRAY- avobenzone, homosalate, octisalate, octocrylene spray

  • NDC Code(s): 83046-360-13, 83046-360-14
  • Packager: Oars and Alps LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 31, 2023

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  • ACTIVE INGREDIENT

    Avobenzone - 2.9%
    Homosalate - 9.8%
    Octisalate - 4.9%
    Octocrylene - 9.5%

  • 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.
    • Flammable. Contents under pressure. Keep away from fire, smoke, other sources of ignition or while smoking. Do not puncture of incinerate can. Do not store above 120 F.
    • 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

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

  • Directions

    • Apply generously and evenly 15 minutes before sun exposure
    • Hold container 4-6 inches from the skin to apply
    • Do not spray directly onto the face. Spray onto hands and rub onto face. Do not inhale.
    • Do not apply in windy conditions.
    • Use in well ventilated area.
    • Reapply: After 80 minutes of swimming or sweating, immedately after towl drying, 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 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 six months: Ask a doctor.
  • INACTIVE INGREDIENT

    Alcohol Denat., Butyloctyl Salicylate, Citrus Paradisi (Grapefruit) Peel Oil, Cladonia Stellaris Extract, Dicaprylyl Carbonate, Diisopropyl Adipate, Ethyl Ferulate, Ethyl Olivate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearoyl Stearate, Isodecyl Neopentanoate, Olea Europaea (Olive) Leaf Extract, Tetrahexyldecyl Ascorbate, Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

  • OTHER SAFETY INFORMATION

    • Protect the product in this container from excessive heat and direct sun
    • Avoid spraying on facbrics - may cause discoloration
  • QUESTIONS

    Contact Hi@oarsandalps.com

  • PRINCIPAL DISPLAY PANEL

    21

  • INGREDIENTS AND APPEARANCE
    OARS AND ALPS SPF 50 HYDRATING ANTIOXIDANT SUNSCREENSPRAY 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83046-360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.8 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ETHYL OLIVATE (UNII: KKJ108Y20W)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    VINYL ACETATE (UNII: L9MK238N77)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    CLADONIA RANGIFERINA WHOLE (UNII: O21ZF987XQ)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83046-360-13177 mL in 1 CAN; Type 0: Not a Combination Product01/01/2021
    2NDC:83046-360-1455 mL in 1 CAN; Type 0: Not a Combination Product01/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02001/01/2021
    Labeler - Oars and Alps LLC (040241941)
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