WESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]

WESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]
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NDC 55312-000-56
Set ID a72e6720-2883-401f-84ab-77d898f87b66
Category HUMAN OTC DRUG LABEL
Packager WESTERN FAMILY FOODS, INC.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3.0%

    Homosalate 15.0%

    Octisalate 5.0%

    Octocrylene 10.0%

    Oxybenzone 6.0%


  • Purpose

    Sunscreen

  • 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

    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 use and ask a doctor

    if rash occurs


    Keep out of the reach of children

    If product is swallowed, get medical help or contact a Poison Control Center right away.


  • OTHER SAFETY INFORMATION

    • May stain some fabrics.
  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply: after 80 minutes of swimming or sweating
    • immediately after towel drying
    • 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. - 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
    • children under 6 months of age: Ask a doctor
  • Inactive ingredients

    Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.

  • Other information

    • protect this product from excessive heat and direct sun
  • Questions or comments?

    Call 1-503-639-6300


  • Principal Display Panel

    WESTERN FAMILY

    Broad Spectrum SPF 70

    sunscreen lotion

    UVA/UVB protection

    moisturizing with vitamin e

    water resistant

    (80 minutes)

    8 FL OZ (236 mL)


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  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY BROAD SPECTRUM SUNSCREEN  SPF 70
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TRICAPRYLIN (UNII: 6P92858988)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-000-56226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/03/2014
    Labeler - WESTERN FAMILY FOODS, INC. (192166072)

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