Label: LIP SHINE SPF35 SUNSCREEN- zinc oxide liquid

  • NDC Code(s): 68078-028-01, 68078-028-02
  • Packager: Colorescience
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Zinc Oxide 6.6%

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

  • Directions

    • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
    • Reapply:
      • After 40 minutes of swimming or sweating.
      • Immediately after towel drying.
      • At least every 2 hours.
    • Children under 6 months: ask a doctor.
    • 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.
  • Inactive ingredients

    Phenyl Trimethicone, Bis-Vinyl Dimethicone/ Dimethicone Copolymer, Neopentyl Glycol Diheptanoate, Disteardimonium Hectorite, Mica, Ethylhexyl Palmitate, Tocopheryl Acetate, Triethyl Citrate, Glyceryl Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Polyhydroxystearic Acid, Tribehenin, Sodium Hyaluronate, Palmitoyl Tripeptide-1, Sorbitan Isostearate, Tin Oxide, Flavor/Aroma, Limonene, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891), Carmine (CI 75470). Contains Carmine as a color additive.

  • Other information

    Protect this product from excessive heat and direct sun.

  • Questions or comments?

    Call toll free 866.426.5673

  • SPL UNCLASSIFIED SECTION

    Distributed in USA
    by Colorescience®
    Carlsbad, CA 92011

  • PRINCIPAL DISPLAY PANEL - 4 mL Tube Carton

    colorescience®

    LIP
    SHINE

    Moisturizes & smooths lips

    Defends against UV rays

    Tint of color, natural shine

    Water resistant
    (40 minutes)

    35

    Broad Spectrum
    SPF 35
    Sunscreen

    0.13 fl. oz. / 4 mL

    PRINCIPAL DISPLAY PANEL - 4 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    LIP SHINE SPF35 SUNSCREEN 
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide66 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    MICA (UNII: V8A1AW0880)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Triethyl Citrate (UNII: 8Z96QXD6UM)  
    Glyceryl Isostearate (UNII: HYE7O27HAO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Palmitoyl Tripeptide-1 (UNII: RV743D216M)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68078-028-011 in 1 CARTON07/01/2017
    14 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:68078-028-021.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product07/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/01/2017
    Labeler - Colorescience (128731929)
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