Safe Sea Spf 50
FDA Label NDC 66134-050

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sasa Cosmetics for the product Safe Sea Spf 50 (NDC 66134-050). 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 inactive ingredient, otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Inactive Ingredient

Inactive Ingredients:  Aqua, Cyclopentasiloxane, Stearyl Dimethicone, Cetyl Dimethicone,

Propylene Glycol, Lauryl PEG / PPG - 18/18 Methicone, Cetyl PEG/PPG-10/1 Dimethicone,

Hydrogenated Castor Oil,  Panthenol, Tocopheryl Acetate, Lanthanum Chloride,

Magnesium Chloride, Calcium Chloride, Plankton Extract, Glycoproteins, Glycosaminoglycans,

Benzyl Alcohol, Fragrance, Chlorphenesin, Benzoic Acid, Sorbic Acid, Dehydroacetic Acid,

Tetrasodium EDTA, Sodium Citrate, Triethoxycaprylylsilane, Trimethoxycaprylylsilane

Otc - Active Ingredient

Active Ingredients:

Octinoxate 7.5 %

Octisalate 5 %

Zinc Oxide 5 %

Titanium Dioxide 2 %

Otc - Purpose

Purpose:

Sunscreen

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 sue 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.

Dosage & Administration

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

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 )

and Rhopilema. Data on file.  - Protect this product form excessive heat

and direct sunlight

Package Label.Principal Display Panel

Copy Of Label (Sasa 50)

Copy Of Label (Sasa 50)

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