NDC | 66134-042-42 |
Set ID | b1040c77-f380-404b-9b1d-f61522f21f2d |
Category | HUMAN OTC DRUG LABEL |
Packager | SASA Cosmetics |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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INACTIVE INGREDIENT
Inactive Ingredients: Aqua, Cyclopentasiloxane, Dicaprylyl Ether,
Isopropyl Myristate, Laurel PEG PPG 18 / 18 Methicone, Isohexadecone,
PEG - 30 Dipolyhydroxystearate, Cetyl Dimethicone, Propylene Glycol,
PVP / Hexadecane Copolymer, Lanthanum Chloride, Magnesium Chloride,
Calcium Chloride, Plankton Extract, Glycoproteins, Glycosaminoglycans,
Fragrance, Chlorphenesin, Trimethoxycaprylylsilane, Tetrasodium EDTA,
Sodium Citrate
- 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 40
octinoxate, octisalate, octocrylene. avobenzone, titanium dioxide, homosalate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66134-042 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 70 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DICAPRYLYL ETHER (UNII: 77JZM5516Z) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) ISOHEXADECANE (UNII: 918X1OUF1E) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LANTHANUM CHLORIDE (UNII: 04M8624OXV) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) CHLORPHENESIN (UNII: I670DAL4SZ) TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66134-042-42 118 g in 1 BOTTLE, SPRAY 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(66134-042) , api manufacture(66134-042)