Label: ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 32 TINTED SUNSCREEN- titanium dioxide and zinc oxide lotion

  • NDC Code(s): 0023-5675-08, 0023-5675-13, 0023-5675-17, 0023-5675-25
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2019

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  • Active ingredients

    Titanium Dioxide 5.0%

    Zinc Oxide 6.0%

  • Purpose

    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 skin 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
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Sun Protection Measures Spending time in 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, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Aluminum Hydroxide, Dimethicone/PEG-10/15 Cross polymer, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Caffeine, Camellia Oleifera Leaf Extract, Tocopheryl Acetate, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxvsilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Stearic Acid, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499)

  • Other information

    • Protect this product 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

    SkinMedica®
    ESSENTIAL
    DEFENSE
    MINERAL SHIELD™
    BROAD SPECTRUM
    SPF 32
    SUNSCREEN
    POST PROCEDURE &
    SENSITIVE SKIN
    TINTED
    SUN PROTECTION
    Net Wt. 1.85 Oz. / 52.5 g

    SkinMedica® ESSENTIAL DEFENSE MINERAL SHIELD™ BROAD SPECTRUM SPF 32 SUNSCREEN POST PROCEDURE & SENSITIVE SKIN TINTED SUN PROTECTION Net Wt. 1.85 Oz. / 52.5 g

  • Principal Display Panel - Tube Label

    SkinMedica®
    ESSENTIAL
    DEFENSE
    MINERAL SHIELD™
    BROAD SPECTRUM
    SPF 32
    SUNSCREEN
    POST-PROCEDURE &
    SENSITIVE SKIN
    TINTED
    SUN PROTECTION
    Net Wt. 1.85 Oz. / 52.5 g

    SkinMedica® ESSENTIAL DEFENSE MINERAL SHIELD™ BROAD SPECTRUM SPF 32 SUNSCREEN POST-PROCEDURE & SENSITIVE SKIN TINTED SUN PROTECTION Net Wt. 1.85 Oz. / 52.5 g

  • INGREDIENTS AND APPEARANCE
    ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 32 TINTED SUNSCREEN 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5675
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide50 mg  in 1 g
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc oxide60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CAFFEINE (UNII: 3G6A5W338E)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-5675-171 in 1 CARTON03/16/2016
    152.5 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0023-5675-081 in 1 CARTON03/16/2016
    2227 g in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0023-5675-256 in 1 CARTON03/16/2016
    37.1 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0023-5675-1312 in 1 CARTON03/16/2016
    43.68 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/16/2016
    Labeler - Allergan, Inc. (144796497)
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