WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]

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  • WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]

WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50 SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]
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NDC 55312-006-22, 55312-006-57
Set ID 41fbb0bf-65ce-409f-9291-3095d28a28b1
Category HUMAN OTC DRUG LABEL
Packager WESTERN FAMILY FOODS, INC.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients

    Avobenzone 3.0 %

    Homosalate 13.0%

    Octisalate 5.0%

    Octocrylene 7.0%

    Oxybenzone 4.0%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decrease 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 reach of children

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

  • 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
  • Other information

    • protect this product from excessive heat and direct sun
  • Inactive ingredients

    Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.


  • Principal Display Panel

    WESTERN FAMILY

    Broad Spectrum SPF 50

    sunscreen lotion

    UVA/UVB protection

    moisturizing with vitamin e

    Water Resistant (80 Minutes)

    3 FL OZ (88 mL)

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    WESTERN FAMILY

    Broad Spectrum SPF 50

    sunscreen lotion

    UVA/UVB protection

    moisturizing with vitamin e

    Water Resistant (80 Minutes)

    10 FL OZ (295 mL)


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  • Questions or comments?

    Call 1-503-639-6300


  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY BROAD SPECTRUM SUNSCREENSPF 50   SPF 50
    avobenzone homosalate octisalate octocrylene oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-006
    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) HOMOSALATE13 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-006-2285 g in 1 BOTTLE, PLASTIC
    2NDC:55312-006-57295 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/02/2014
    Labeler - WESTERN FAMILY FOODS, INC. (192166072)
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