Label: SEA PURE HYDRATING SEA PURE HYDRATING SPF20- titanium dioxide lotion

  • 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


    Titanium Dioxide4.0%


    Helps prevent sunburns
    If used as directed with other sun protection measure ( 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 is a rash occurs
    When using this product* 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
    Children under six months of age: Ask a doctor

    Protect this product in this container from excessive heat and direct sunlight

    Enter section text here

  • PRINCIPAL DISPLAY PANEL

    Image of carton label sphl295.jpgimage of carton label

  • INGREDIENTS AND APPEARANCE
    SEA PURE HYDRATING  SEA PURE HYDRATING SPF20
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40 uL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CORN OIL (UNII: 8470G57WFM)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LIMONENE, (-)- (UNII: 47MAJ1Y2NE)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ULVA COMPRESSA (UNII: SXZ209FM33)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    LEMON OIL (UNII: I9GRO824LL)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)  
    LIME OIL (UNII: UZH29XGA8G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65903-295-011 in 1 CARTON
    150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/10/2010
    Labeler - H2O PLUS (807722947)
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