The following Structured Product Label (SPL) was submitted to the FDA by Sasa Cosmetics for the product Safe Sea (NDC 66134-015). 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.
Inactive Ingredients: Aqua, Cyclopentasiloxane, Mineral Oil, Lauryl
PEG/PEG - 18/18 Methicone, Cetyl
Dimethicone, Stearyl Dimethicone, Ceresin,
Hydrogenated Castor Oil, Propylene Glycol,
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
Active Ingredients:
Octinoxate 7.5 %
Zinc Oxide 2 %
Purpose:
Sunscreen
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
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.
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.
Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.
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 from excessive heat and direct sunlight.
Copy Of Label (Sasa 15)
* Please review the disclaimer below.
