Label: FACE POTION- avobenzone, homosalate, octisalate, octocrylene 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 February 15, 2018

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  • SPL UNCLASSIFIED SECTION

    OP Dab-On Spot stick SPF 50

    Drug Facts

  • Active Ingredients:

    Avobenzone 2.5%

  • Active Ingredients:

    Homosalate 15.0%

  • Active Ingredients:

    Octisalate 5.0%

  • Active Ingredients:

    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

    • Stop use and ask a doctor

    if rash or irritation develops.

    • When using this product

    keep out of eyes. Rinse with water to remove.

    • Keep out of reach of children.

    If accidentally swallowed, contact a Poison Control Center right away.

    • Do not use

    near heat or open flames. Keep treated skin away from fire, sparks or flames until dry.

  • Directions:

    • Apply liberally 15 minutes before sun exposure, depress sponge top to initial product application

    • Re-apply:

          • after 80 minutes of swimming or sweating

          • immediately after towel drying

          • at least every two 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 value 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-sleeved shirts, pants, hats and sunglasses

    • Children under 6 months: ask a doctor.

  • Inactive Ingredients

    Acrylates/Octylacrylamide Copolymer, Cholecalciferol, Denatured Alcohol, Dimethyl Capramide, Glycerin, Polyester-8

  • Other Information

    • for use on skin only. Avoid contact with fabric - protect this product from excessive heat and direct sun.

  • Questions or comments?

    Call toll free 1-800-715-3485

  • PRINCIPAL DISPLAY PANEL

    DAB- ON
    Spot Stick Sunscreen
    50 SPF
    65 FL OZ (19mL)

    PRINCIPAL DISPLAY PANEL DAB- ON Spot Stick Sunscreen 50 SPF 65 FL OZ (19mL)

  • INGREDIENTS AND APPEARANCE
    FACE POTION 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-204
    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) OCTOCRYLENE7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70281-204-0419 g in 1 CONTAINER; Type 0: Not a Combination Product09/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/15/2015
    Labeler - SolSkyn Personal Care LLC (080010329)
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