Label: SAFE SEA SUNSCREEN WITH JELLYFISH STING PROTECTIVE SPF 50- octinoxate, octisalate, zinc oxide, 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 November 12, 2011

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  • Active Ingredients

    Active Ingredients                                                                                         Purpose
    Octinoxate 7.5 %, Octisalate 5 %, Zinc Oxide 5 %, Titanium Dioxide 2 %.....Sunscreen

  • Uses

    - Helps prevent sunburn.  - Sun Protection Factor 50.  - Retains SPF after 80 minutes of activity in the water or perspiring.

  • Warning

    - For external use only.

  • When using this product

    keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor

    if skin irritation or rash develops.

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Immediately.

  • Directions

    - Adults and children six months of age and older. Apply Liberally to all exposed areas 10 minutes before sun or water exposure.  - Ensure complete coverage.  - Reapply after prolonged swimmimg and towel drying.

  • Other Information

    - Give particular attention to coverage of arms and legs.  - In water infested by Sea Lice, Safe Sea should also be applied under the bathing suit. Jellyfish can be dangerous. This product should not be considered a recommendation to go into jellyfish infested water, nor is it a guarantee against stings.  - In case of sting do not use Safe Sea as a treatment - seek medical attention.  * Tested against Sea nettle (Chrysaora), Atlantic Box jellyfish (Chiropsalmus) and Rhopilema. Date on file.

  • Inactive ingredients

    Deionized Water, Cyclomethicone, Lauryl PEG/PPG-18/18 Methicon, Cetyl dimethicone, Stearyl Dimethicone, Ceresine, Hydrogenated Castor Oil, Plankton extract, Propylene Glycol, Propylparaben, Methylparaben, Chlorphenesin, Lanthanum Chloride, Magnesium Chloride, Sodium Citrate, Tetrasodium EDTA, Triethoxycaprylylsilane, Trimethoxycaprylylsilane, Glycoproteins, Glycosaminoglycans, Fragrance, Calcium Chloride.

  • Purpose

    Sunscreen

  • Description

    SAFE SEA Sunscreen SPF 50 With Jellyfish Sting Protective Lotion  The world's only sunscreen lotion scientifically developed to help prevent the stings from most jellyfish*, Sea nettle, Sea lice (Seabathers eruption).  Dermatologist tested. UVAandUVB protection For sensitive skin. Water resistant.  Distributed by  Nidaria Technology ltd.  420 Lexington Avenue Suite 2400 New York, New York 10170  Made in Israel. www.nidaria.com  US Patents No. 6338837 / 6406709 / 6132747  NDC - 0654350150  7 13026 10150 6

  • PRINCIPAL DISPLAY PANEL

    SAFE SEA Sunscreen SPF 50 With Jellyfish Sting Protective Lotion

  • PRINCIPAL DISPLAY PANEL

    SAFE SEA Sunscreen with JELLYFISH STING PROTECTIVE LOTION SPF 50 Helps Prevent Stings from Jellyfish and Sea Lice  UVA, UVB, Water Resistant Clinically Tested  4 fl. oz. (118 ml)

  • Product Package Outer Label A

    Safe Sea SPF 50 A

  • Product Package Outer Label B

    Safe Sea SPF 50 B

  • INGREDIENTS AND APPEARANCE
    SAFE SEA SUNSCREEN WITH JELLYFISH STING PROTECTIVE SPF 50 
    octinoxate, octisalate, zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65435-0151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    SODIUM DICHLOROACETATE (UNII: 42932X67B5)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65435-0151-5118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2011
    Labeler - Nidaria Technology Ltd. (514977487)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cellango Crystalline Ltd.532199064manufacture
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