OCEAN POTION INSTANT DRY 30 MIST WATER SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [SUN & SKIN CARE RESEARCH, LLC]

OCEAN POTION INSTANT DRY 30 MIST WATER SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [SUN & SKIN CARE RESEARCH, LLC]
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NDC 62802-651-06
Set ID bb7a1ab3-5fc2-4409-a962-53d714c5d604
Category HUMAN OTC DRUG LABEL
Packager Sun & Skin Care Research, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Homosalate: 13%
    Octisalate: 5%
    Octocrylene: 6%
    Avobenzone: 3%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • If used as directed with other skin 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. Stop use and ask a doctor if rash occurs. When using this product keep away from face to avoid breathing in.  Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.  Flammable  Do not use near heat, flame or while smoking.  Avoid long term storage above 104°F (40°C).  Avoid spraying in eyes.  Contents under pressure.  Do not puncture or incinerate.  Do not store in temperatures above 120°F.

  • Directions

    • spray evenly and liberally on all exposed areas 15 minutes before sun exposure.  Ensure skin is completely covered with product
    • hold can 4-6 inches away from the skin to apply
    • do not spray directly on face.  Spray on hands then apply to face
    • do not apply in windy conditions.  Use in a well-ventilated area
    • reapply after 80 minutes of swimming or sweating and immediately after towel 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 limiting time in the sun, especially from 10a.m.-2p.m., wear long-sleeved shirts, pants hats and sunglasses.
    • children under 6 months: Ask a doctor
  • Other Information

    • For use on skin only
    • Avoid contact with fabric
    • Protect this product from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    OCEAN POTION INSTANT DRY 30 MIST WATER SPORT SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-651
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE13 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62802-651-06177 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2014
    Labeler - Sun & Skin Care Research, LLC (849772207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun & Skin Care Research, LLC849772207manufacture(62802-651)

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