Label: PROTECTION 50 SPORT- homosalate, octocrylene, octisalate, and avobenzone lotion

  • NDC Code(s): 68479-232-00, 68479-232-02
  • Packager: Dermalogica, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 8, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone (3.0%)
    Octisalate (5.0%)
    Homosalate (10.0%)
    Octocrylene (10.0%)

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), helps 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 help 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: ask a doctor.
  • Other information

    • Protect this product from excessive heat and direct sun.
  • Inactive ingredients

    Water/Aqua/Eau, Carthamus Tinctorius (Safflower) Oleosomes, Butylene Glycol, Dimethicone, Methyl Methacrylate Crosspolymer, C15-19 Alkane, VP/ Eicosene Copolymer, Silica, Dimethyl Capramide, Polyglyceryl-2 Stearate, Squalane, Dipotassium Glycyrrhizate, Arachidyl Glucoside, Glyceryl Stearate SE, PEG-100 Stearate, Arachidyl Alcohol, Potassium Cetyl Phosphate, Dimethicone Crosspolymer, Behenyl Alcohol, Xanthan Gum, Acrylates/C10- 30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Ethylhexylglycerin, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, Citric Acid, Phenoxyethanol.

  • Questions or comments

    Call toll free 1-800-831-5150 in the US

  • PRINCIPAL DISPLAY PANEL - 156 mL Tube Carton

    protection
    50
    sport

    SPF
    50

    broad spectrum

    80 minutes
    water-resistant

    5.3 US FL OZ / 156 mL ℮

    dermalogica

    PRINCIPAL DISPLAY PANEL - 156 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    PROTECTION 50 SPORT 
    homosalate, octocrylene, octisalate, and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-232
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 mg  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene10 mg  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 mg  in 100 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    C15-19 Alkane (UNII: CI87N1IM01)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Dimethyl Capramide (UNII: O29Y6X2JEZ)  
    Polyglyceryl-2 Stearate (UNII: 253MC0P0YV)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Squalane (UNII: GW89575KF9)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-232-021 in 1 CARTON08/05/2019
    1156 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-232-002 mL in 1 POUCH; Type 0: Not a Combination Product08/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/05/2019
    Labeler - Dermalogica, LLC. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway052400223MANUFACTURE(68479-232)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!