Label: TRACI LYNN SKIN ILUMINATOR BROAD SPECTRUM SPF 50- octinoxate, zinc oxide lotion

  • 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 January 1, 2020

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  • Active Ingredients

    Octinoxate 7.5%

    Zinc Oxide 9%

  • 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 80 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 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.
  • Inactive Ingredients

    Butylene Glycol, Cyclopentasiloxane, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides, Isopropyl Palmitate, Niacinamide, Octyl Stearate, Octyldodecyl Neopentanoate, Oleth-3 Phosphate, PEG-7 Trimethylolpropane Coconut Ether, Phenoxyethanol, Polyisobutene, Sodium Hyaluronate, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

  • Other information

    • Protect this product from excessive heat and direct sun.
  • Questions or comments?

    Mafactured for TRACI LYNN BEAUTY, LLC

    954.717.448 / www.tracilynnbeauty.com

  • Traci Lynn Skin Illuminator Sunscreen Broad Spectrum SPF 50

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    TRACI LYNN SKIN  ILUMINATOR BROAD SPECTRUM SPF 50
    octinoxate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE80.475 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE96.57 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    OXT-101 (UNII: 622325VBYO)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Product Characteristics
    Colorbrown (Nude) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0295-350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/18/2018
    Labeler - Prime Enterprises (101946028)
    Registrant - Prime Enterprises (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises101946028pack(58443-0295) , manufacture(58443-0295) , label(58443-0295) , analysis(58443-0295)
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