Label: LBEL DEFENSE TOTAL COMPACT SUNCREEN SPF 50 FOR FACE - MATTE FINISH- octinoxate, octocrylene, and zinc oxide cream

  • 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 June 12, 2017

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    OCTINOXATE 7%Sunscreen
    OCTOCRYLENE 5%Sunscreen
    ZINC OXIDE 16.66%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.

    • 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 and evenly 15 minutes before sun exposure.
    • Reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • Children under 6 months of age: Ask a doctor
    • 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.
  • Other information

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

    DIMETHICONE, ZEA MAYS (CORN) STARCH, POLYMETHYLSILSESQUIOXANE, POLYETHYLENE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, MICA, OZOKERITE, BUTYROSPERMUM PARKII (SHEA) BUTTER, SORBITAN SESQUIOLEATE, PEG/PPG-18/18 DIMETHICONE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, DIISOPROPYL ADIPATE, COPERNICIA CERIFERA (CARNAUBA) WAX, TOCOPHERYL ACETATE, CERAMIDE 3, CAPRYLYL GLYCOL, CHLORPHENESIN, PHYSALIS ANGULATA EXTRACT, FRAGRANCE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SILICA, TRIMETHYLSILOXYSILICATE, OXOTHIAZOLIDINE, LINALOOL.

    MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES.

  • SPL UNCLASSIFIED SECTION

    Dist. by Ventura Corp. Ltd.,
    San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 9,5 g Container Box

    MEDIUM

    L'BEL
    DÉFENSETOTAL

    HIGH PROTECTION
    SPF
    50

    compact cream sunscreen
    for face - matte finish

    BROAD SPECTRUM
    WATER RESISTANT (40 minutes)

    Net Wt. 0.34 oz. e (9,5 g)

    PRINCIPAL DISPLAY PANEL - 9,5 g Container Box
  • INGREDIENTS AND APPEARANCE
    LBEL DEFENSE TOTAL COMPACT SUNCREEN SPF 50 FOR FACE - MATTE FINISH 
    octinoxate, octocrylene, and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.05 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.1666 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    MICA (UNII: V8A1AW0880)  
    CERESIN (UNII: Q1LS2UJO3A)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    OXOTHIAZOLIDINE (UNII: M6U1ZG59XD)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0062-21 in 1 BOX04/18/2017
    1NDC:43596-0062-19.5 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/18/2017
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(43596-0062)
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!