Safe Sea Spf 30 Lotion
FDA Label NDC 65435-0600

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 30 (NDC 65435-0600). 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 ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 10.9%

Purpose

Sunscreen

Uses

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

Warnings

  • For external use only 
  • Do not use on damagedor broken skin
  • When using this productkeep out of eyes. Rinse with water to remove
  • Stop use and ask a doctorif rash occurs
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure 
  • reapply: After 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours 
  • Sun Protection MeasuresSpending 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.

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

Inactive Ingredients

Benzoic Acid, Benzyl Alcohol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Chloride, Caprylic / Capric triglyceride, Chlorphenisine, Dehydroacetic Acid, Dibutyl Adipate, Hydrogenated Castor Oil, Lanthanum Chloride, Magnesium Chloride, Magnesium Stearate, Panthenol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-4 Diisostearate /Polyhydroxystearate/Sebacate, Sorbic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

* Please review the disclaimer below.