Label: SAFE SEA SPF 40- octocrylene, homosalate, ethylhexyl salicylate, butyl methoxydibenzoylmethane liquid
- NDC Code(s): 65435-0300-1
- Packager: NIDARIA TECHNOLOGY LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 9, 2023
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
: Aqua, Dibutyl Adipate, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Dicaprylyl Ether, PEG-30 Dipolyhydroxystearate, Lauryl PEG/PPG-18/18 Methicone, Isopropyl Myristate, Stearyl Dimethicone, Cetyl dimethicone, Propylene Glycol, VP/Hexadecene Copolymer, Panthenol, Tocopheryl Acetate, Lanthanum Chloride, Magnesium Chloride, Calcium Chloride, Plankton Extract, Glycoproteins, Glycosaminoglycans, Parfum, Chlorphenisin. Inactive Ingredients
- INDICATIONS & USAGE
- WARNINGS
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INSTRUCTIONS FOR USE
: ■ 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. Directions
- KEEP OUT OF REACH OF CHILDREN
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OTHER SAFETY 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) & Rhopilema. Data on file. ■ Protect this product from excessive heat and direct sun. Other Information
- DOSAGE & ADMINISTRATION
- PURPOSE
- Product label
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INGREDIENTS AND APPEARANCE
SAFE SEA SPF 40
octocrylene, homosalate, ethylhexyl salicylate, butyl methoxydibenzoylmethane liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65435-0300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIBUTYL ADIPATE (UNII: F4K100DXP3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DICAPRYLYL ETHER (UNII: 77JZM5516Z) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LANTHANUM CHLORIDE (UNII: 04M8624OXV) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) CHLORPHENESIN (UNII: I670DAL4SZ) PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65435-0300-1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/01/2021 Labeler - NIDARIA TECHNOLOGY LTD (514977487)
