WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.]

WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.]
PDF | XML

NDC 55312-017-57
Set ID dda7975f-29f2-4870-89cc-cea8828b64e4
Category HUMAN OTC DRUG LABEL
Packager WESTERN FAMILY FOODS, INC.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone   2.0%

    Homosalate   10.0%

    Octisalate       5.0%

    Octocrylene    5.0%

  • 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. 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, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Triethanolamine, Disodium EDTA, Carbomer, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Chlorphenesin, Fragrance.

  • Other Information

    •  protect this product from excessive heat and direct sun
  • Principal Display Panel

    WESTERN FAMILY

    Broad Spectrum

    SPF 15

    sunscreen lotion

    UVA/UVB protection

    moisturizing with vitamin e

    water resistant

    (80 minutes)

    10 FL OZ (295 mL)


    hthtyrled.jpg

  • Questions or comments?

    Call 1-503-639-6300


  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY  SPF 15
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SORBITOL (UNII: 506T60A25R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-017-57290 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/07/2014
    Labeler - WESTERN FAMILY FOODS, INC. (192166072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Playtex Manufacturing Inc963501502manufacture(55312-017)

Related Drugs