Safe Sea Spf 50 Lotion
FDA Label NDC 65435-0100

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 65435-0100). 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 indications & usage, warnings, otc - keep out of reach of children, other safety information, questions or comments?, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications & Usage

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

Warning: ■ 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 

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Other Safety Information

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.

Principal Display Panel

Front Label

Front (Front50)

Front (Front50)

Back Label

Back (Back50)

Back (Back50)

* Please review the disclaimer below.