OCEAN POTION GENTLE AND SENSITIVE 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [SUN & SKIN CARE RESEARCH, LLC]

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OCEAN POTION GENTLE AND SENSITIVE 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [SUN & SKIN CARE RESEARCH, LLC]
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NDC 62802-182-08
Set ID dd2decbd-969e-4763-933c-f19d870c3ec2
Category HUMAN OTC DRUG LABEL
Packager Sun & Skin Care Research, LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredients

    • Homosalate: 15%
    • Octisalate: 5%
    • Octocrylene: 7%
    • 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 out of eyes.  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.

  • Directions 

    • apply liberally 15 minutes before sun exposure
    • 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 GENTLE AND SENSITIVE 50 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-182
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62802-182-08237 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2012
    Labeler - Sun & Skin Care Research, LLC (849772207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun & Skin Care Research, LLC849772207manufacture(62802-182)
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