Label: OBAGI 360 HYDRAFACTOR MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, octinoxate, octisalate, and oxybenzone cream

  • NDC Code(s): 62032-300-09, 62032-300-37
  • Packager: OBAGI COSMECEUTICAL LLC
  • 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 September 3, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 1%Sunscreen
    Octinoxate 7.5%Sunscreen
    Octisalate 5%Sunscreen
    Oxybenzone 5%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

    Stop use and ask a doctor if rash occurs

    When using this product keep out of eyes. If product gets into eyes, rinse with water to remove.

    Keep out of reach of children. If 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 your risk of skin cancer and early skin aging. 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
    • children under 6 months: Ask a doctor
  • Other information

    • store at controlled room temperature: 15°C–25°C (59°F–77°F)
    • protect this product from excessive heat and direct sun
  • Inactive ingredients

    water (aqua), C12-15 alkyl benzoate, butyloctyl salicylate, glycerin, sodium hyaluronate, eperua falcata bark extract, dextrin, polysorbate 20, hydrolyzed caesalpinia spinosa gum, caesalpinia spinosa gum, sodium hydroxide, carbomer, acrylates/C10-30 alkyl acrylate crosspolymer, caprylyl glycol, disodium EDTA, hexylene glycol, pichia/resveratrol ferment extract, sorbitan oleate, tocopheryl acetate, ubiquinone, phenoxyethanol, ethylhexylglycerin

  • Questions or comments?

    1.800.636.7546

    Monday–Friday 9 a.m.–4 p.m. Pacific Time

  • SPL UNCLASSIFIED SECTION

    Distributed by Obagi Cosmeceuticals LLC,
    Long Beach, CA 90806

  • PRINCIPAL DISPLAY PANEL - 75 g Tube Carton

    OBAGI®
    MEDICAL

    OBAGI360®

    HydraFactor™
    Moisturizing Cream
    with Sunscreen

    Broad Spectrum
    SPF 30

    Net wt. 2.5 oz. (75 g)

    Principal Display Panel - 75 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    OBAGI 360 HYDRAFACTOR MOISTURIZING BROAD SPECTRUM SPF 30  SUNSCREEN
    avobenzone, octinoxate, octisalate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-300
    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) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    CAPRYLIC ALCOHOL (UNII: NV1779205D)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EPERUA FALCATA BARK (UNII: L43J05M2KO)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-300-371 in 1 CARTON01/02/201412/31/2019
    175 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:62032-300-091 in 1 CARTON01/01/2020
    275 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/02/2014
    Labeler - OBAGI COSMECEUTICAL LLC (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S Cosmeceutical017014734MANUFACTURE(62032-300) , LABEL(62032-300) , PACK(62032-300)
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