OCEAN POTION SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [SOLSKYN PERSONAL CARE LLC]

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  • OCEAN POTION SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [SOLSKYN PERSONAL CARE LLC]

OCEAN POTION SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [SOLSKYN PERSONAL CARE LLC]
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NDC 70281-504-24
Set ID 7ebcc977-c5ae-4720-b201-7d7d32896090
Category HUMAN OTC DRUG LABEL
Packager SolSkyn Personal Care LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    OP SPF 30 Lotion

  • Active Ingredients

    Avobenzone 3%, Homosalate 8%, Octisalate 4.5%, Octocrylene 6%

  • 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: keep away from fire or flame.

    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.

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

  • Directions

    • apply liberally 15 minutes before sun exposure
    • re-apply:
      • after 80 minutes of swimming or sweating
      • 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 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-sleeved shirts, pants, hats and sunglasses
    • children under 6 months: ask a doctor
  • Other information

    • protect this product from excessive heat and direct sun
    • For use on skin only. Avoid contact with fabric.
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C), C28-52 Olefin/Undecylenic Acid Copolymer, Caprylyl Glycol, Cetearyl Alcohol, Diisopropyl Adipate, Dimethicone, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Hydrogenated Palm Glycerides, Laminaria Saccharina Extract, Macrocystis Pyrifera Extract, Neopentyl Glycol Diheptanoate, PEG-16 Macadamia, PEG-100 Stearate, Phenethyl Benzoate, Phenoxyethanol, Polyglyceryl-3 Methylglucose Distearate, Potassium Cetyl Phosphate, Pyridoxine HCl (Vitamin B6), Sodium Hydroxide, Tapioca Starch Polymethylsilsesquioxane, Thermus Thermophillus Ferment, Tocopheryl Acetate (Vitamin E), Trisiloxane, Water, Xanthan Gum

  • Questions or comments?

    www.oceanpotion.com call toll-free 1-800-715-3485

    MAY STAIN SOME FABRICS, PLASTICS AND WOOD SURFACES.

  • PRINCIPAL DISPLAY PANEL

    OCEAN
    POTION
    SUNCARE
    30
    SUNSCREEN LOTION
    Scent of sunshine
    3.4 FL OZ (100 mL)

    PRINCIPAL DISPLAY PANEL OCEAN POTION SUNCARE 30 SUNSCREEN LOTION Scent of sunshine 3.4 FL OZ (100 mL)

  • INGREDIENTS AND APPEARANCE
    OCEAN POTION SPF30 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-504
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mg
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 mg  in 100 mg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 mg  in 100 mg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    LAMINARIA SACCHARINA EXTRACT (UNII: 68CMP2MB55)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    PEG-16 MACADAMIA GLYCERIDES (UNII: 2OTC93KMHU)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70281-504-24100 mg in 1 BOTTLE; Type 0: Not a Combination Product09/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/15/2017
    Labeler - SolSkyn Personal Care LLC (080010329)
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