DAILY DEFENCE SHIELD SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [ELEMIS LIMITED]

DAILY DEFENCE SHIELD SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [ELEMIS LIMITED]
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NDC 65912-003-41, 65912-003-43
Set ID b2b6de93-47c8-4b6e-9fb9-8bdc8909271a
Category HUMAN OTC DRUG LABEL
Packager ELEMIS Limited
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 1.4% }
    Octinoxate 1.4% }
    Octocrylene 0.7%}

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally and evenly 15 minutes before sun exposure and as needed
    • children under 6 months of age: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses
      • reapply at least every 2 hours
      • use a water resistant sunscreen if swimming or sweating
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    Water, Glycerin, Coco-Caprylate, Isostearyl Alcohol, Butylene Glycol Cocoate, Cetyl Alcohol, Phenoxyethanol, Panthenol, Butylene Glycol, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Carbomer, Sodium Stearoyl Glutamate, Chondrus Crispus Powder, Lecithin, 1,2-Hexanediol, Ethylcellulose, Tocopherol, Ethylhexylglycerin, Argania Spinosa Leaf Extract, Carnosine, Tocopheryl Acetate, Disodium EDTA, Sodium Hydroxide, Biosaccharide Gum-4, Melanin, Pentylene Glycol.

  • Questions?

    US T: 1-855-235-3647

  • PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

    ADVANCED SKINCARE

    ELEMIS

    DAILY DEFENCE
    SHIELD SPF 30

    Broad Spectrum SPF 30
    Sunscreen

    • Sun protection for all skin types
    • Enviro-Age Complex, Coconut,
      Jojoba
    • Defends, protects, hydrates

    40 ml e 1.3 US fl.oz.

    Principal Display Panel - 40 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    DAILY DEFENCE SHIELD  SPF 30
    avobenzone, octinoxate, and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65912-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE14 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE14 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65912-003-411 in 1 CARTON06/04/2018
    140 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:65912-003-4340 g in 1 TUBE; Type 0: Not a Combination Product06/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/04/2018
    Labeler - ELEMIS Limited (399838895)

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