SUNRIGHT BROAD SPECTRUM SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [NSE PRODUCTS, INC.]

SUNRIGHT BROAD SPECTRUM SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [NSE PRODUCTS, INC.]
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NDC 62839-1332-1
Set ID 8c0d9b96-624d-416a-a84d-3c62cfc31bdf
Category HUMAN OTC DRUG LABEL
Packager NSE Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5%, Oxybenzone 5%.

  • Purpose

    Sunscreen

  • Use

    • Helps prevent sunburn. Higher SPF gives more sunburn protection.
    • 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

    • For external use only.

    • Do not use on damaged or broken skin

    • Stop use and ask a doctor if rash occurs

    • When using this product, keep out of eyes. Rinse with water to remove.

    • 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 40 minutes of swimming or sweating
      • Immediately after towel drying
      • At least every 2 hours
    • Children under 6 months: Ask a doctor
    • Sunprotection 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.–2p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Inactive Ingredients

    Water, Octyldodecyl Neopentanoate, Butylene Glycol, Glycerin, Aluminum Starch Octenylsuccinate, Triacontanyl PVP, Chlorella Vulgaris Extract, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Stearyl Glycyrrhetinate, PEG-20 Almond Glycerides, Hydrogenated Castor Oil, Boron Nitride, Xanthan Gum, Silica Dimethyl Silylate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Alcohol, Stearic Acid, Carbomer, Tetrasodium EDTA, Aminomethyl Propanol, Fragrance, Phenoxyethanol, Chlorphenesin, Methylparaben, Propylparaben, Ethylparaben, Benzyl Alcohol.

  • Other Information

    • Protect this product from excessive heat and direct sun.
  • Questions?

    1-888-742-7626

  • PRINCIPAL DISPLAY PANEL - 100 ml Tube Carton

    SUNRIGHT®

    with SeaLastin

    BROAD SPECTRUM
    SPF 30

    Face & Body Sunscreen
    Water Resistant (40 Minutes)

    100 ml e (3.4 FL. OZ.)

    Principal Display Panel - 100 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    SUNRIGHT BROAD SPECTRUM SPF 30 
    avobenzone, octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-1332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    Chlorella Vulgaris (UNII: RYQ4R60M02)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
    Boron Nitride (UNII: 2U4T60A6YD)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Ethylparaben (UNII: 14255EXE39)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-1332-11 in 1 CARTON
    1100 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/01/2010
    Labeler - NSE Products, Inc. (803486393)

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