SAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]

SAFE SEA SPF 40 (OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]
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NDC 66134-040-40
Set ID e5f6e3dc-d03e-451d-9a6e-a26985b8491c
Category HUMAN OTC DRUG LABEL
Packager SASA Cosmetics
Generic Name
Product Class
Product Number
Application Number PART352
  • INACTIVE INGREDIENT

    Inactive Ingredients:  Aqua, Cyclopentasiloxane, Stearyl Dimethicone,

    Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propylene

    Glycol, Cetyl dimethicone, Lanthanum Chloride, Magnesium Chloride,

    Calcium Chloride, Plankton Extract, Glycoproteins, Glycosaminoglycans,

    Benzyl Alcohol, Fragrance, Chlorphenesin, Benzoic Acid, Sorbic Acid,

    Dehydroacetic Acid, Tetrasodum EDTA, Sodium Citrate, Trimethoxycaprylylsilane

  • ACTIVE INGREDIENT

    Active Ingredients:

    Octinoxate 7.5 %

    Octisalate 5 %

    Octocrylene 3.5%

    Avobenzone 3 %

    Titanium Dioxide 1.5 %

  • 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.

  • 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 form excessive heat

    and direct sunlight

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    SAFE SEA SPF 40 
    octinoxate, octisalate, octocrylene. avobenzone, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66134-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE35 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    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)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66134-040-40118 g in 1 TUBE; Type 0: Not a Combination Product01/07/201504/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/07/201504/30/2022
    Labeler - SASA Cosmetics (600481230)
    Establishment
    NameAddressID/FEIBusiness Operations
    SASA Cosmetics600481230manufacture(66134-040) , api manufacture(66134-040)

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