SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]

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  • SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]

SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]
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NDC 61010-6103-0, 61010-6103-1, 61010-6103-2, 61010-6103-3
Set ID 754186c8-3c88-40a0-a4e3-35e3ea9d1b4c
Category HUMAN OTC DRUG LABEL
Packager Safetec of America, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Homosalate (6.0%)

    Octinoxate (7.5%)

    Octisalate (5.0%)

    Oxybenzone (5.0%)

  • Purpose

    Sunscreens

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • for skin highly sensitive to sunburn
  • 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, get medical help or contact a poison control center right away

  • Directions

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

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

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – 25 count box

    NDC 61010-6103-1

    Safetec

    Sunscreen
    Lotion
    SPF 30

    PABA Free

    25 Packets

    3.5 g (1/8 oz.)

    Reorder no. 53700

    PRINCIPAL DISPLAY PANEL – 25 count box
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – packet

    Safetec

    Sunscreen
    Lotion
    SPF 30•PABA Free
    3.5g (1/8 oz.)

    Safetec of America, Inc.
    Buffalo, NY 14215 800-456-7077
    www.safetec.com

    PRINCIPAL DISPLAY PANEL – packet
  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    homosalate, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-6103
    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:61010-6103-125 in 1 BOX03/13/2007
    1NDC:61010-6103-03.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:61010-6103-325 in 1 BOX07/01/2018
    2NDC:61010-6103-22 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/13/2007
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(61010-6103)
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