Label: ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN- titanium dioxide and zinc oxide lotion

  • NDC Code(s): 0023-5703-08, 0023-5703-17, 0023-5703-25
  • 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 March 2, 2016

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

View All Sections
  • 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 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 Crosspolymer, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Caffeine, Camellia Oleifera Leaf Extract, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Stearic Acid, Ethylhexylglycerin, Phenoxyethanol

  • 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 35
    SUNSCREEN
    POST-PROCEDURE &
    SENSITIVE SKIN
    SUN PROTECTION
    Net Wt. 1.85 Oz. / 52.5 g

    SkinMedica® ESSENTIAL DEFENSE MINERAL SHIELD™ BROAD SPECTRUM SPF 35 SUNSCREEN POST-PROCEDURE & SENSITIVE SKIN SUN PROTECTION Net Wt. 1.85 Oz. / 52.5 g

  • Principal Display Panel - Tube Label

    SkinMedica®
    ESSENTIAL
    DEFENSE
    MINERAL SHIELD™
    BROAD SPECTRUM
    SPF 35
    SUNSCREEN
    POST-PROCEDURE &
    SENSITIVE SKIN
    SUN PROTECTION
    Net Wt. 1.85 Oz. / 52.5 g

    SkinMedica® ESSENTIAL DEFENSE MINERAL SHIELD™ BROAD SPECTRUM SPF 35 SUNSCREEN POST-PROCEDURE & SENSITIVE SKIN SUN PROTECTION Net Wt. 1.85 Oz. / 52.5 g

  • INGREDIENTS AND APPEARANCE
    ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5703
    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)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CAFFEINE (UNII: 3G6A5W338E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-5703-171 in 1 CARTON03/16/2016
    152.5 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0023-5703-081 in 1 CARTON03/16/2016
    2227 g in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0023-5703-256 in 1 CARTON03/16/2016
    37.1 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)
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!