DYNAMIC SKIN RECOVERY SPF 50 (AVOBENZONE AND OCTINOXATE) LOTION [DERMALOGICA, INC.]

DYNAMIC SKIN RECOVERY SPF 50 (AVOBENZONE AND OCTINOXATE) LOTION [DERMALOGICA, INC.]
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NDC 68479-318-00, 68479-318-02, 68479-318-04
Set ID d6a52af9-969b-4666-af96-c0d14bb6627c
Category HUMAN OTC DRUG LABEL
Packager Dermalogica, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone (3.0%)
    Octinoxate (7.5%)

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), helps decrease 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 rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 30 minutes before sun exposure
    • Reapply at least every two hours
    • Use a water-resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 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-sleeve shirts, pants, hats and sunglasses
    • Do not use on infants under 6 months old.
  • Other information

    • Protect this product from excessive heat and direct sun.
  • Inactive ingredients

    Water/Aqua/Eau, Butylene Glycol, Carthamus Tinctorius (Safflower) Oleosomes, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Glycerin, Dimethicone, Dimethyl Capramide, Palmitoyl Tripeptide-5, Aniba Rosaeodora (Rosewood) Wood Oil, Rose Flower Oil, Pelargonium Graveolens Flower Oil, Helianthus Annuus (Sunflower) Seed Oil, Eugenia Caryophyllus (Clove) Leaf/ Flower Oil, Citrus Medica Limonum (Lemon) Peel Oil, Saccharomyces Cerevisiae Extract, Camellia Sinensis Leaf Extract, Citrus Medica Limonum (Lemon) Peel Extract, Algae Extract, Dipotassium Glycyrrhizate, Lecithin, Glucosamine HCL, Arginine/Lysine Polypeptide, Tocopheryl Acetate, Squalane, Sodium Hyaluronate, Polysilicone-11, Glycine Soja (Soybean) Protein, 1,2-Hexanediol, Caprylic/Capric Trilyceride, Cetearyl Alcohol, Stearic Acid, Ceteareth-20, Sodium Polyacrylate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Acrylates Copolymer, Decyl Glucoside, Polysorbate 80, Urea, Galactoarabinan, Glyceryl Polyacrylate, Polysorbate 60, Aminomethyl Propanol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Titanium Dioxide (CI77891).

  • Questions or comments

    Call toll free 1-800-831-5150 in the US.

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    dynamic
    skin
    recovery

    spf
    50

    broad
    spectrum

    UVA high protection

    AGE smart®

    1.7 US FL OZ
    50 mL e

    dermalogica®

    Principal Display Panel - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DYNAMIC SKIN RECOVERY   SPF 50
    avobenzone and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Dimethyl Capramide (UNII: O29Y6X2JEZ)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.S At 1%) (UNII: 86FQE96TZ4)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Squalane (UNII: GW89575KF9)  
    Polysilicone-15 (UNII: F8DRP5BB29)  
    Egg Phospholipids (UNII: 1Z74184RGV)  
    Galactoarabinan (UNII: SL4SX1O487)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Rosewood Oil (UNII: F2522O5L7B)  
    Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Sodium Polyacrylate (8000 MW) (UNII: 285CYO341L)  
    Lemon Oil (UNII: I9GRO824LL)  
    Clove Leaf Oil (UNII: VCA5491KVF)  
    Urea (UNII: 8W8T17847W)  
    Glucosamine Hydrochloride (UNII: 750W5330FY)  
    Saccharomyces Lysate (UNII: R85W246Z1C)  
    Palmitoyl Tripeptide-5 (UNII: 2A3916MQHO)  
    Decyl Glucoside (UNII: Z17H97EA6Y)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Lemon Peel (UNII: 72O054U628)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-318-021 in 1 CARTON
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68479-318-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68479-318-002 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/09/2013
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paklab790530976MANUFACTURE(68479-318)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-318)

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