Label: DEFENSE TOTAL HIGH PROTECTION SPF 50 NO COLOR DAILY NON-GREASY FACE PROTECTION- homosalate, octocrylene, avobenzone lotion

  • 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 December 2, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Homosalate 10.00% Sunscreen

    Octocrylene 8.00% Sunscreen

    Avobenzone 3.00% Sunscreen

  • PURPOSE

    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.
  • 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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • DOSAGE & ADMINISTRATION

    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.

    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 your time in the sun, especially from 10

    a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses

    • Children under 6 months of age: ask a doctor.

  • WARNINGS

    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.

  • OTHER SAFETY INFORMATION

    Other information:

    • Protect the product in this container from excessive heat and direct sun
  • INACTIVE INGREDIENT

    lnactive lngredients
    Water, styrene/acrylates copolymer, potassium cetyl phosphate, c12·15 alkyl benzoate, cyclohexasiloxane, dimethicone,
    phenethyl benzoate,polymethylsilsesquioxane, propylene glycol, vp/eicosene copolymer, trimethylsiloxysilicate, phenoxyethanol,

    cetyl palmitate, xanthan gum, physalis angulata extract, caprylic/capric triglyceride, cetearyl alcohol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, acrylates/c10·30 alkyl acrylate crosspolymer, caprylyl glycol, disodium edta, tocopheryl acetate, citric acid, butylene glycol, oxothiazolidine.

  • PRINCIPAL DISPLAY PANEL

    Defense Total High Protection SPF 50

    No color

    Water resistant (40 minutes)

    with collagen protectors

    daily non-greasy

    Face protection Lotion

    1 fl. oz. (30 ml)

    Defense Total 30 CJ-56739-B

  • INGREDIENTS AND APPEARANCE
    DEFENSE TOTAL HIGH PROTECTION SPF 50 NO COLOR DAILY NON-GREASY FACE PROTECTION 
    homosalate, octocrylene, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OXOTHIAZOLIDINE (UNII: M6U1ZG59XD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0140-130 mL in 1 BOX; Type 0: Not a Combination Product06/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/29/2020
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197manufacture(43596-0140)
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!