FDA Label for Safe Sea
View Indications, Usage & Precautions
Safe Sea Product Label
The following document was submitted to the FDA by the labeler of this product Sasa Cosmetics. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Inactive Ingredient
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
Otc - Active Ingredient
Active Ingredients:
Octinoxate 7.5 %
Zinc Oxide 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 from excessive heat and direct sunlight.
Package Label.Principal Display Panel
* Please review the disclaimer below.