NDC | 65435-0131-5 |
Set ID | 244e26cb-1f14-4b40-99b1-1b0d32785b94 |
Category | HUMAN OTC DRUG LABEL |
Packager | Nidaria Technology Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Uses
- Warning
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
- Directions
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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.
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Inactive ingredients
Deionized Water, Cyclomethicone, Lauryl PEG/PPG-18/18 Methicon, Cetyl dimethicone, Stearyl Dimethicone, Mineral Oil, 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
-
Description
SAFE SEA Sunscreen SPF 30 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 - 0654350130 7 13026 10130 8
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- Product Package Outer Label A
- Product Package Outer Label B
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INGREDIENTS AND APPEARANCE
SAFE SEA SUNSCREEN WITH JELLYFISH STING PROTECTIVE SPF 30
octinoxate, octisalate, oxybenzone, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65435-0131 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE 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:65435-0131-5 118 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