Safe Sea Spf 50 Lotion
FDA Label NDC 65435-0800

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 Spf 50 (NDC 65435-0800). 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 uses, warnings, directions, otc - keep out of reach of children, other safety information, inactive ingredients, questions or comments?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

  •  Helps prevent sunburn 
  •  If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun. 

Warnings

  • For external use only
  • Do not useon damaged or broken skin 
  • When using this productkeep out of eyes. Rinse with water to remove 
  • Stop use and ask a doctorif rash occurs 

Directions

  • Apply liberally 15 minutes before sun exposure 
  • reapply: After 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours 
  • Sun Protection Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  •  Limit time in the sun, especially from 10 a.m.to 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses 
  • Children under 6 months: Ask a doctor. 

Otc - Keep Out Of Reach Of Children

Other Safety 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) & Rhopilema. Data on file. 
  • Protect this product from excessive heat and direct sun. 

Inactive Ingredients

Aqua, Dibutyl Adipate, Polyglyceryl 2 Dipolyhydroxystearate, Stearyl Dimethicone, Cetyl Dimethicone, Magnesium Stearate, Hydrogenated Castor Oil, Benzyl alcohol, Lanthanum Chloride, Magnesium Chloride, Calcium Chloride, Glycosaminoglycans, Glycoproteins, Plankton Extract, Parfum(Fragrance), Chlorphenisin, Panthenol, Tocopheryl Acetate, Dehydroacetic Acid, Benzoic Acid, Sorbic Acid 

Product Label

Image Description (Image 001)

Image Description (Image 001)

* Please review the disclaimer below.