NDC 65435-0116 Safe Sea Sunscreen With Jellyfish Sting Protective Spf 15

NDC Product Code 65435-0116

NDC CODE: 65435-0116

Proprietary Name: Safe Sea Sunscreen With Jellyfish Sting Protective Spf 15 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 65435 - Nidaria Technology Ltd.
    • 65435-0116 - Safe Sea Sunscreen With Jellyfish Sting Protective Spf 15

NDC 65435-0116-5

Package Description: 118 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Safe Sea Sunscreen With Jellyfish Sting Protective Spf 15 with NDC 65435-0116 is a product labeled by Nidaria Technology Ltd.. The generic name of Safe Sea Sunscreen With Jellyfish Sting Protective Spf 15 is . The product's dosage form is and is administered via form.

Labeler Name: Nidaria Technology Ltd.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nidaria Technology Ltd.
Labeler Code: 65435
Start Marketing Date: 11-12-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Safe Sea Sunscreen With Jellyfish Sting Protective Spf 15 Product Label Images

Safe Sea Sunscreen With Jellyfish Sting Protective Spf 15 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Active Ingredients                                                          PurposeOctinoxate 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

* Please review the disclaimer below.