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 December 9, 2025

If you are a consumer or patient please visit this version.

  • Active Ingredients                                                                   Purpose

    Octocrylene 10%                                                                     Sunscreen

    Homosalate 10%                                                                     Sunscreen

    Octisalate 5%                                                                          Sunscreen

    Avobenzone 3%                                                                       Sunscreen

  • PURPOSE

  • 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 use 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

  • 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) & Rhopilema. Data on file. 
    • Protect this product from excessive heat and direct sun.
  • Inactive ingredients

    C12-15 Alkyl Benzoate, Calcium Chloride, Cetyl Dimethicone, Chlorphenesin, Cyclopentasiloxane, Dibutyl Adipate, Dicetyl Phthalate, Dimethicone, Fragrance, Glycoproteins, Glycosaminoglycans, Hydrogenated Castor Oil, Laureth-9, PEG/PPG-18/18 Methicone, Magnesium Chloride, Panthenol, PEG-30 Dipolyhydroxystearate, Plankton Extract, Propanediol, Stearyl Dimethicone, Tocopheryl Acetate, VP/Hexadecene Copolymer, Water.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    SAFE SEA SPF 40 
    octocrylene, homosalate, ethylhexyl salicylate, butyl methoxydibenzoylmethane liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65435-0300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    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)  
    POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65435-0300-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2021
    Labeler - NIDARIA TECHNOLOGY LTD (514977487)