Label: SEA RESULTS LINE RESOLUTION SEA RESULTS LINE RESOLUTION SPF30- avobenzone,homosalate,octisalate,oxybenzone cream

  • 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 September 29, 2011

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  • ACTIVE INGREDIENT


    Avobenzone 3.0%
    Homosalate 8.0%
    Octisalate 4.0%
    Oxybenzone 5.0%

    Sunscreen
    Sunscreen
    Sunscreen
    Sunscreen

    • Helps prevent sunburn
    • If used as directed with other sun protection measures
    (see directions) decreases the risk of skin cancers and early skin aging

    • For external use only • Do not use on damaged or broken skin
    • Stop use and ask a doctor if rash occurs

    • Keep out of eyes, Rinse with water to remove. Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away

    • For Sunscreen use
    • Apply liberally 15 minutes before sun exposure
    • Use water resistance sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: Ask a doctor

    Protect the product in this container from excessive heat
    and direct sun

    Acetyl Hexapeptide-8, Alcohol, Aqua/Water/Eau,
    Benzoic Acid, Butylene Glycol, Butylparaben,
    C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl
    Glucoside, Cyclopentasiloxane, Dehydroacetic
    Acid, Dimethicone, Ethylhexylglycerin,
    Ethylparaben, Glycerin, Glyceryl Stearate,
    Himanthalia Elongata Extract, Isobutylparaben,
    Linalool, Magnesium Ascorbyl Phosphate,
    Methylisothiazolinone, Methylparaben,
    Panthenol, Parfum/Fragrance, Phenoxyethanol,
    Phospholipids, Polyaminopropyl Biguanide,
    Porphyra Umbilicalis Extract, Potassium Sorbate,
    Propylparaben, Retinyl Palmitate, Silica,
    Solidago Virgaurea (Goldenrod) Extract,
    Spirulina Maxima Extract, Tocopheryl Acetate,
    Triethanolamine, Trisiloxane, Tropaeolum Majus
    Flower Extract, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    Image of Label Carton srlr276.jpgImage of Label Carton

  • INGREDIENTS AND APPEARANCE
    SEA RESULTS LINE RESOLUTION  SEA RESULTS LINE RESOLUTION SPF30
    avobenzone,homosalate,octisalate,oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-276
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mL  in 100 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate8 mL  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate4 mL  in 100 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HIMANTHALIA ELONGATA (UNII: 21RND18XRR)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50)  
    SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TRIETHANOLAMINE HYDROCHLORIDE (UNII: R297UJ9QDY)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65903-276-011 in 1 CARTON
    150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2012
    Labeler - H2O PLUS (807722947)
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