3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]

3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]
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NDC 76159-124-01, 76159-124-02
Set ID d539b851-c4b2-40a2-9562-e3a95a86b744
Category HUMAN OTC DRUG LABEL
Packager 3LAB, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts


  • Active Ingredients

    Octinoxate 7.5%
    Octisalate 4.6%
    Avobenzone 2.0%

  • Purpose

    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.

    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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • 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 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
    • Children under 6 months:  Ask a doctor
  • Other Information

    Protect this product from excessive heat and direct sun

  • Inactive Ingredients

    Water (Aqua/Eau), Propylene Glycol, Glyceryl Sterate, PEG-100 Stearate, Caprylic/Capric triglyceride, STearic Acid, Cetyl Alcohol, Dimethicone, Sodium Hyaluronate, Tocopheryl Acetate, Allantoin, Panthenol, Sodium PCA, Ceramide 2, Acrylates/C-10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin

  • Hydra Day SPF 20

    Water-based Sunscreen

    A multi-tasking moisturizer to guard against environmental damage.  Provide luxurious hydration, and give skin a silky finish for flawless makeup application.  Fortified with 3LAB's exclusive proprietary complex. a synergistic blend of powerful natural polyphenol antioxidants, and advanced moisturizers:  it acts as a superior anti-aging product, with broad-spectrum sunscreen protection.  Light, luminous and quickly absorbed.  Just Perfect!

  • PRINCIPAL DISPLAY PANEL

    3LAB  Hydra Day SPF 20 BROAD SPECTRUM  Water-based Sunscreen     NET WT. 2 OZ. / 60 mL e

  • Product Label

    Hydra Day

  • INGREDIENTS AND APPEARANCE
    3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN  
    octinoxate, octisalate, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76159-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE46 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76159-124-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2017
    2NDC:76159-124-026 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/15/2012
    Labeler - 3LAB, Inc (162333277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080987545manufacture(76159-124)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab Korea Co., Ltd.690104005manufacture(76159-124)

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