Label: GOODSENSE SPF 50 CSPRAY- avobenzone, homosalate, octisalate, octocrylene spray

  • 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 August 7, 2019

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 15%

    Octisalate 5%

    Octocrylene 10%

  • 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

    Do not use on damaged or broken skin.

  • When using this product

    When using this product keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor

    Stop use and ask a doctor if rash occurs.

  • Flammable

    Flammable: ● do not use near heat, flame or while smoking ● avoid long –term storage above 104oF(40oC) ● do not puncture or incinerate ● contents under pressure ● do not store at temperature above 120oF(49oC).

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Hold 4-6 inches from skin and spray over arms, legs, and body in a continuous motion, then quickly rub into skin. Do not spray directly onto face; spray on hands and then apply to face.
    • Apply liberally 15 minutes before sun exposure
    • Re-apply:
      • 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 broad-spectrum SPF of 15 or high and other sun protection measures including:

    • Limit time in the sun, especially from 10a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
    • Children under 6 months: Ask a doctor
  • Other Information

    • Protect the product in this container from excessive heat and direct sun
    • For use on skin only, avoid contact with fabric
  • Questions

    Distributed by:

    Geiss, Destin & Dunn, Inc.

    Peach tree City, GA 30269

    www.valuelabels.com

    800-715-3485

    GoodSense® is a registered trademark of L. Perrigo Company

  • Principal Display Panel

    GOODSENSE

    SUNSCREEN

    CONTINUOUS

    SPRAY

    BROAD SPECTRUM

    SPF 50

    Water Resistant

    (80 Minutes)

    UVA/UVB Protection
    Spray at Any Angle
    Oxybenzone Free

    *Compare and Save 100% Satisfaction Guaranteed

    NET WT 5.5 OZ (155 g)

    GoodSense SPF 50 Cspray TC_Trimline Can_Label.jpg

  • INGREDIENTS AND APPEARANCE
    GOODSENSE SPF 50 CSPRAY 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-634
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70281-634-25155 g in 1 CAN; Type 0: Not a Combination Product04/23/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/23/2019
    Labeler - Solskyn Personal Care LLC (080010329)
    Establishment
    NameAddressID/FEIBusiness Operations
    KIK Piedmont LLC078482780manufacture(70281-634)
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