DYNAMIC RESURFACING SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [ELEMIS LIMITED]

DYNAMIC RESURFACING SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [ELEMIS LIMITED]
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NDC 65912-002-50, 65912-002-51
Set ID fc64720c-060c-4f33-8c76-96456fac270d
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 1.0% }
    Octinoxate 1.0% }
    Octocrylene 0.5% }

  • 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, Coco-Caprylate, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Isostearyl Alcohol, Butylene Glycol, Butylene Glycol Cocoate, Rubus Idaeus (Raspberry) Seed Oil, Phenoxyethanol, Tocopheryl Acetate, Carbomer, Chlorphenesin, Melissa Officinalis Leaf Extract, Propylene Glycol, Sodium Stearoyl Glutamate, Behenyl Alcohol, Ethylcellulose, Lecithin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Tocopherol, Papain, Borago Officinalis Seed Oil, Fragrance, Disodium EDTA, Sodium Hydroxide, Sodium Dehydroacetate, Hydrogenated Castor Oil, Stearyl Alcohol, Euphrasia Officinalis Extract, Mimosa Tenuiflora Bark Extract, Protease, Biosaccharide Gum-1, Citric Acid, Codium Tomentosum Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Myrtus Communis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Subtilisin, Poria Cocos Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Oil.

  • Questions?

    US T: 1-855-235-3647

  • PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

    ANTI-AGEING

    ELEMIS

    DYNAMIC RESURFACING
    DAY CREAM SPF 30

    Skin smoothing day cream
    Broad Spectrum SPF 30 | Sunscreen

    💧
    For uneven, dull skin
    💧
    Tri – Enzymes, Poria Cocos, Raspberry Seed oil
    💧
    Renews, smoothes, hydrates

    50 ml e 1.6 US fl.oz.

    PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
  • INGREDIENTS AND APPEARANCE
    DYNAMIC RESURFACING  SPF 30
    avobenzone, octinoxate, and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65912-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE10 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PAPAIN (UNII: A236A06Y32)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EUPHRASIA STRICTA (UNII: C9642I91WL)  
    MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
    ECKLONIA CAVA (UNII: UXX2N5V39P)  
    GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)  
    SARGASSUM FUSIFORME (UNII: X436TJ4A11)  
    MYRTUS COMMUNIS LEAF (UNII: U20N87188F)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUBTILISIN (UNII: 0ZP13EBC5Y)  
    FU LING (UNII: XH37TWY5O4)  
    CITRUS AURANTIUM LEAFY TWIG OIL (UNII: 5K6H1IMT3D)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65912-002-501 in 1 CARTON03/05/2018
    150 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:65912-002-5150 g in 1 JAR; Type 0: Not a Combination Product03/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/05/2018
    Labeler - ELEMIS Limited (399838895)

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