Safe Sea Spf 50 Mineral Lotion
FDA Label NDC 65435-0400

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 Mineral (NDC 65435-0400). 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, other information, warnings, directions, uses, 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 21%

Purpose

Sunscreen

Other Information

  • Give perticular 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 be considered a recommendation to go into jellyfish infested water, nor is it guarantee against stings.
  • In case of stings do not use Safe sea as a treatement - seek medical attention. *Tested against sea nettle (Chrysaora), Atlantic box jellyfish (Chiropsalmus) & Rhopilema.Data on file.
  • Protect this product from excessive heat and direact sun.

Warnings

  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if 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 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
  • Sun protection Measure- Spending time in the sun increase your 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 10a.m. to 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months : Ask a doctor

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

Inactive Ingredients

Benzoic acid, Benzyl alcohol, Bis-Octyldodecyl, Dimer Dilinoleate/ Propanediol copolymer, Butyloctyl Salicylate, C12 -15 Alkyl benzoate, Calcium chloride, Caprylic / Capric triglyceride, Chlorphenesin, Dehydroacetic acid, Dibutyl Adipate, Hydrogenated Caster oil, Isopropyl Myristate, Lanthanum chloride, Magnesium Chloride, Magnesium stearate, Panthenol, Polyglycerly-2Dipolyhydroxystearate, Sorbic acid, Tocopheryl Acetate, Triethoxycaprylylsilane, water.

Product Label

Image Description (Image 1)

Image Description (Image 1)

* Please review the disclaimer below.