Label: SAFE SEA SPF 50- octinoxate, octisalate, avobenzone, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 66134-050-50 - Packager: SASA Cosmetics
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 7, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
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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.
- KEEP OUT OF REACH OF CHILDREN
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SAFE SEA SPF 50
octinoxate, octisalate, avobenzone, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66134-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 50 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LANTHANUM CHLORIDE (UNII: 04M8624OXV) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) BENZYL ALCOHOL (UNII: LKG8494WBH) CHLORPHENESIN (UNII: I670DAL4SZ) BENZOIC ACID (UNII: 8SKN0B0MIM) SORBIC ACID (UNII: X045WJ989B) DEHYDROACETIC ACID (UNII: 2KAG279R6R) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66134-050-50 118 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/07/2015 Labeler - SASA Cosmetics (600481230) Establishment Name Address ID/FEI Business Operations SASA Cosmetics 600481230 manufacture(66134-050) , api manufacture(66134-050)
