Active Ingredients
Active Ingredients Purpose
Octinoxate 7.5 %, Zinc Oxide 2 %.............................Sunscreen
Safe Sea Sunscreen With Jellyfish Sting Protective Spf 15
FDA Label NDC 65435-0116
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nidaria Technology Ltd. for the product Safe Sea Sunscreen With Jellyfish Sting Protective Spf 15 (NDC 65435-0116). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, uses, warning, when using this product, stop use and ask a doctor, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Package Label.Principal Display Panel
SAFE SEA Sunscreen SPF 15 With Jellyfish Sting Protective Lotion
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 (Safeseaspf15a)
Product Package Outer Label B
Safe Sea Spf 15 B (Safeseaspf15b)
* Please review the disclaimer below.
