Label: ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN- zinc oxide and octinoxate lotion

  • NDC Code(s): 0023-5738-18, 0023-5738-25
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 2, 2016

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  • Active ingredients

    Octinoxate 7.5%

    Zinc Oxide 12.0%

  • 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, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Camellia Sinensis Leaf Extract, Polygonum Aviculare Extract, Tocopheryl Acetate, Sodium Hyaluronate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Butylene Glycol, Disodium EDTA, Sodium Hydroxide, Citric Acid, Caprylyl Glycol, Sorbic Acid, Phenoxyethanol, Ethylhexylglycerin

  • 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
    EVERYDAY CLEAR™
    BROAD SPECTRUM
    SPF 47
    SUNSCREEN
    OILY &
    COMBINATION SKIN
    SUN PROTECTION
    Net Wt. 1.85 Oz. / 52.5 g

    SkinMedica® ESSENTIAL DEFENSE EVERYDAY CLEAR™ BROAD SPECTRUM SPF 47 SUNSCREEN OILY & COMBINATION SKIN SUN PROTECTION Net Wt. 1.85 Oz. / 52.5 g

  • Principal Display Panel - Tube Label

    SkinMedica®
    ESSENTIAL
    DEFENSE
    EVERYDAY CLEAR™
    BROAD SPECTRUM
    SPF 47
    SUNSCREEN
    OILY &
    COMBINATION SKIN
    SUN PROTECTION
    Net Wt. 1.85 Oz. / 52.5 g

    SkinMedica® ESSENTIAL DEFENSE EVERYDAY CLEAR™ BROAD SPECTRUM SPF 47 SUNSCREEN OILY & COMBINATION SKIN SUN PROTECTION Net Wt. 1.85 Oz. / 52.5 g

  • INGREDIENTS AND APPEARANCE
    ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN 
    zinc oxide and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5738
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SORBIC ACID (UNII: X045WJ989B)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-5738-181 in 1 CARTON03/16/2016
    152.5 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0023-5738-256 in 1 CARTON03/16/2016
    27.1 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/16/2016
    Labeler - Allergan, Inc. (144796497)
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