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
  • 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 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 not finalpart35203/16/2016
    Labeler - Allergan, Inc. (144796497)
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