Label: SEAWEED OIL-CONTROL SPF 15- octisalate, avobenzone, octinoxate, and octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 10, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Avobenzone (3.0% w/w)Sunscreen
    Octinoxate (2.9% w/w)Sunscreen
    Octisalate (5.0% w/w)Sunscreen
    Octocrylene (2.2% w/w)Sunscreen
  • Uses

    • helps prevent sunburn.
  • Warnings

    • For external use only.

    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.
    • 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 sun especially from 10 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses.
      • reapply this product at least every 2 hours.
      • use a water resistant sunscreen if swimming or sweating.
    • children under 6 months of age: ask a doctor.
  • Other information

    • protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients

    Water, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Butylene Glycol, Caprylic/Capric Triglyceride, Sorbitol, Cetearyl Alcohol, Potassium Cetyl Phosphate, Dimethicone, Phenoxyethanol, Bertholletia Excelsa Seed Oil, Caprylyl Glycol, Fragrance, Xanthan Gum, Carbomer, Potassium Sorbate, Tetrasodium EDTA, Pentylene Glycol, Propylene Glycol, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fucus Vesiculosus Extract, Linalool, Zinc Gluconate, Benzyl Salicylate, Acacia Senegal Gum, Hydrolyzed Wheat Protein, Propylene Glycol Alginate, BHT, Hydrolyzed Algin, Serine, Sodium Stearate, Zinc Sulfate.

  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Label

    THE
    BODY
    SHOP

    THE BODY SHOP
    SEAWEED

    OIL-CONTROL LOTION
    BROAD SPECTRUM SPF 15 SUNSCREEN

    WITH MINERAL-RICH SEAWEED
    FROM ROARING WATER BAY, IRELAND

    50 ml (1.69 US FL OZ)

    COMBINATION / OILY SKIN

    Principal Display Panel - 50 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    SEAWEED OIL-CONTROL SPF 15 
    octisalate, avobenzone, octinoxate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57691-904
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.029 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.022 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Sorbitol (UNII: 506T60A25R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    BRAZIL NUT OIL (UNII: 0G89T29HO6)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Carboxypolymethylene (UNII: 0A5MM307FC)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Zinc Gluconate (UNII: U6WSN5SQ1Z)  
    Benzyl Salicylate (UNII: WAO5MNK9TU)  
    ACACIA (UNII: 5C5403N26O)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    Propylene Glycol Alginate (UNII: 26CD3J2R0C)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Serine (UNII: 452VLY9402)  
    Sodium Stearate (UNII: QU7E2XA9TG)  
    Zinc Sulfate, Unspecified Form (UNII: 89DS0H96TB)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57691-904-5050 mL in 1 TUBE; Type 0: Not a Combination Product04/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/14/2016
    Labeler - Buth-Na-Bodhaige, Inc., (791071279)
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