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Safe Sea Sunscreen With Jellyfish Sting Protective SPF 15 (Nidaria Technology Ltd.)

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LOTION 118 mL in 1 BOTTLE (65435-0116-5) Label Information

Complete Safe Sea Sunscreen With Jellyfish Sting Protective SPF 15 Information

  • Active Ingredients

    Active Ingredients                                                          Purpose
    Octinoxate 7.5 %, Zinc Oxide 2 %.............................Sunscreen


  • Uses

    - Helps prevent sunburn.  - Sun Protection Factor 15.  - 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, Mineral Oil, Lauryl PEG/PPG-18/18 Methicon, Cetyl dimethicone, Stearyl Dimethicone, Ceresine, Hydrogenated Castor Oil, Plankton extract, Propylene Glycol, Diazolidinyl Urea, Propylparaben, Methylparaben, Lanthanum Chloride, Magnesium Chloride, Sodium Citrate, Tetrasodium EDTA, Trimethoxycaprylylsilane, Glycoproteins, Glycosaminoglycans, Fragrance, Calcium Chloride.


  • Purpose

    Sunscreen


  • Description

    SAFE SEA Sunscreen SPF 15 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 - 0654350115  7 13026 10115 5


  • PRINCIPAL DISPLAY PANEL

    SAFE SEA Sunscreen SPF 15 With Jellyfish Sting Protective Lotion


  • PRINCIPAL DISPLAY PANEL

    SAFE SEA Sunscreen with JELLYFISH STING PROTECTIVE LOTION SPF 15 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 15 A


  • Product Package Outer Label B

    Safe Sea SPF 15 B


  • INGREDIENTS AND APPEARANCE
    SAFE SEA SUNSCREEN WITH JELLYFISH STING PROTECTIVE SPF 15 
    octinoxate, zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65435-0116
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE 2 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM DICHLOROACETATE (UNII: 42932X67B5)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65435-0116-5 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 11/12/2011
    Labeler - Nidaria Technology Ltd. (514977487)
    Establishment
    Name Address ID/FEI Business Operations
    Cellango Crystalline Ltd. 532199064 manufacture