Label: DYNAMIC SKIN RECOVERY SPF 50- avobenzone and octinoxate lotion

  • NDC Code(s): 68479-318-00, 68479-318-01, 68479-318-02, 68479-318-03, view more
    68479-318-04
  • Packager: Dermalogica, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 14, 2022

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  • 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 Rosodora (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, Laminaria Digitata 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 Triglyceride, 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 - 12 mL Bottle Carton

    hydrating, firming
    age defense

    dynamic
    skin
    recovery

    SPF
    50

    high
    protection

    UVA
    UVB
    broad spectrum

    dermalogica
    skin care by The International Dermal Institute

    AGE Smart

    0.4 US FL OZ / 12 mL e

    Principal Display Panel - 12 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)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Dimethyl Capramide (UNII: O29Y6X2JEZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Squalane (UNII: GW89575KF9)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Galactoarabinan (UNII: SL4SX1O487)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Gluconic Acid (UNII: R4R8J0Q44B)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ROSEWOOD OIL (UNII: F2522O5L7B)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    1-DEHYDRO-7.ALPHA.-METHYLTESTOSTERONE (UNII: CRW83OBW6B)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    CLOVE OIL (UNII: 578389D6D0)  
    Urea (UNII: 8W8T17847W)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
    Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    ROSA X ALBA FLOWER OIL (UNII: FF1Y064QVO)  
    Palmitoyl Tripeptide-5 (UNII: 2A3916MQHO)  
    Tocopherol (UNII: R0ZB2556P8)  
    Decyl Glucoside (UNII: Z17H97EA6Y)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LEMON PEEL (UNII: 72O054U628)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Cupressus Sempervirens Leaf Oil (UNII: M7QUY89S4O)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Cymbopogon Schoenanthus Oil (UNII: XE7K568ILO)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Eugenol (UNII: 3T8H1794QW)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Geraniol (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-318-011 in 1 CARTON12/09/2013
    112 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68479-318-021 in 1 CARTON12/09/2013
    250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68479-318-031 in 1 CARTON12/09/2013
    3100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:68479-318-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/09/2013
    5NDC:68479-318-002 mL in 1 POUCH; Type 0: Not a Combination Product12/09/2013
    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
    Cosway052400223MANUFACTURE(68479-318)
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