Label: SUNFREE SUNSCREEN- homosalate, octinoxate, octisalate, oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 7, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    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 2 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 - Packet Label

    SUNFREE™
    SUNSCREEN

    SPF 30 PABA Free

    Net contents 3.5g (1/8 oz.)

    Mfd for:

    Afassco::®

    Minden, NV 89423

    800-441-6774

    Principal Display Panel - Packet Label

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  • INGREDIENTS AND APPEARANCE
    SUNFREE SUNSCREEN 
    homosalate, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-6103
    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)  
    ETHYL PYRROLIDONE (UNII: H0229SX1CW)  
    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)  
    PEG-8 Dimethicone (UNII: GIA7T764OD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51532-6103-13.5 g in 1 PACKET; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2014
    Labeler - Afassco (609982723)
    Registrant - Safetec of America, Inc (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc 874965262MANUFACTURE(51532-6103)
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