SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]

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SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]
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NDC 55550-102-01
Set ID 7d4f820d-e154-428e-89c2-2e26e088ceef
Category HUMAN OTC DRUG LABEL
Packager Total Resources International
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • for skin highly sensitive to sunburn
  • Active Ingredients

    Homosalate (6.0%), Octinoxate (7.5%), Octisalate (5.0%), Oxybenzone (5.0%)

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: ask a doctor
    • protect from excessive heat and direct sun
  • Warnings

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
    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 swallowed, contact a poison control center right away

  • Inactive ingredients

    cetyl alcohol, ganex P-904, germaben II, polyoxyl 40 stearate, polysorbate 60, petrolatum, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX

  • PRINCIPAL DISPLAY PANEL – packet

    Sunscreen Lotion
    SPF 30

    1.5 g. (0.0570 oz.)

    PRINCIPAL DISPLAY PANEL – packet
  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    homosalate, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55550-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate6 mg  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mg  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 mg  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    cetyl alcohol (UNII: 936JST6JCN)  
    povidone K30 (UNII: U725QWY32X)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    methylparaben (UNII: A2I8C7HI9T)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    polyoxyl 40 stearate (UNII: 13A4J4NH9I)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    petrolatum (UNII: 4T6H12BN9U)  
    water (UNII: 059QF0KO0R)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    edetate sodium (UNII: MP1J8420LU)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    xanthan gum (UNII: TTV12P4NEE)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    dimethicone (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55550-102-011.5 g in 1 PACKET; Type 0: Not a Combination Product03/13/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/13/2007
    Labeler - Total Resources International (790160535)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(55550-102)
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