Label: TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 SUNSCREEN- octinoxate, octisalate and zinc oxide lotion

  • NDC Code(s): 0023-5494-01, 0023-5494-23, 0023-5494-25
  • Packager: Allergan, Inc.
  • 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 September 14, 2015

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

  • Active ingredients

    Octinoxate 7.5%

    Octisalate 3.0%

    Zinc Oxide 8.0%

  • Purpose

    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, Silica, Squalane, 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, Panthenol, Butylene Glycol, Ceteareth-20, Polyhydroxystearic Acid, Isostearic Acid, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA, Aminomethyl Propanol, Caprylyl Glycol, Potassium Sorbate, Sorbic Acid, Phenoxyethanol

  • 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
    Net Wt. 6 x 1.0 Oz. Travel

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

  • INGREDIENTS AND APPEARANCE
    TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 SUNSCREEN 
    octinoxate, octisalate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5494
    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
    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)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SQUALENE (UNII: 7QWM220FJH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SHEANUT OIL (UNII: O88E196QRF)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    BETAINE (UNII: 3SCV180C9W)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    2'-HYDROXYACETOPHENONE (UNII: 3E533Z76W0)  
    BATILOL (UNII: 39YR661C4U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SORBIC ACID (UNII: X045WJ989B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-5494-231 in 1 CARTON06/15/2015
    165 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0023-5494-011 in 1 CARTON06/15/2015
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0023-5494-256 in 1 CARTON06/15/2015
    37.08 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/15/2015
    Labeler - Allergan, Inc. (144796497)