Label: TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 SUNSCREEN (TINTED)- octinoxate, octisalate, titanium dioxide and zinc oxide lotion

  • NDC Code(s): 0023-5497-01, 0023-5497-08, 0023-5497-23, 0023-5497-25
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 21, 2015

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredients

    Octinoxate 7.5%

    Octisalate 3.0%

    Titanium Dioxide 3.5%

    Zinc Oxide 8.0%

  • Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours and after towel drying, swimming, or sweating to avoid lowering protection
    • Sun Protection Measures UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun from 10 a.m.-2 p.m., and wearing protective clothing
    • children under 6 months: Ask a doctor
  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Squalane, Silica, Glycerin, Niacinamide, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Polygonum Aviculare Extract, Physalis Angulata Extract, Dunaliella Salina Extract, Ubiquinone, Camellia Sinensis Leaf Extract, Tremella Fuciformis Sporocarp Extract, Betaine, Melanin, Tocopheryl Acetate, Tocopherol, Hydroxyacetophenone, Batyl Alcohol, C12-15 Alkyl Benzoate, PEG-12 Dimethicone, Panthenol, Butylene Glycol, Ceteareth-20, Polyhydroxystearic Acid, Isostearic Acid, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA, Aminomethyl Propanol, Caprylyl Glycol, Potassium Sorbate, Sorbic Acid, Phenoxyethanol, Iron Oxides (77491,77492,77499)

  • Other information

    • protect the product in this container from excessive heat and direct sun
    • store at room temperature 15°- 30°C (59°- 86°F)
  • Questions or comments

    www.skinmedica.com

  • Principal Display Panel - Carton Label

    TOTAL DEFENSE
    +
    REPAIR
    Broad Spectrum SPF 34 Sunscreen
    + INFRARED PROTECTION
    TINTED
    Net Wt. 6 x 1.0 Oz Travel

    TOTAL DEFENSE + REPAIR Broad Spectrum SPF 34 Sunscreen + INFRARED PROTECTION TINTED Net Wt. 6 x 1.0 Oz Travel

  • INGREDIENTS AND APPEARANCE
    TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 SUNSCREEN (TINTED) 
    octinoxate, octisalate, titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5497
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SQUALANE (UNII: GW89575KF9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    BATILOL (UNII: 39YR661C4U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BETAINE (UNII: 3SCV180C9W)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-5497-231 in 1 CARTON06/15/2015
    165 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0023-5497-011 in 1 CARTON06/15/2015
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0023-5497-256 in 1 CARTON06/15/201506/30/2024
    37.08 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0023-5497-081 in 1 CARTON06/15/2015
    4227 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/15/2015
    Labeler - Allergan, Inc. (144796497)
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

More Info on this Drug

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