SAFE SEA SPF 50 (OCTINOXATE, OCTISALATE, AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]

SAFE SEA SPF 50 (OCTINOXATE, OCTISALATE, AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]
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NDC 66134-050-50
Set ID ac7ee36b-a361-4240-b7a3-1b36e298cf7a
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, 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

    Active Ingredients:

    Octinoxate 7.5 %

    Octisalate 5 %

    Zinc Oxide 5 %

    Titanium Dioxide 2 %

  • 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 50 
    octinoxate, octisalate, avobenzone, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66134-050
    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
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66134-050-50118 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/07/2015
    Labeler - SASA Cosmetics (600481230)
    Establishment
    NameAddressID/FEIBusiness Operations
    SASA Cosmetics600481230manufacture(66134-050) , api manufacture(66134-050)

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