Label: TINTED LIP SHIELD- zinc oxide and homosalate cream

  • NDC Code(s): 79356-203-01, 79356-203-02
  • Packager: OneKind.25
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients

    Homosalate 8 %

    Zinc Oxide 5.6 %

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Indication & Usage

    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


    Warnings


    Do not use on damaged or
    broken skin.

  • DO NOT USE


    Do not use on damaged or
    broken skin.

  • WHEN USING

    When using this product keep out of eyes

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children.
    If swallowed, get medical help
    or contact a poison control center right away

  • DOSAGE & ADMINISTRATION


    Directions Apply generously
    15 minutes before sun
    exposure. Reapply at least
    every 2 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
    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

  • OTHER SAFETY INFORMATION


    Protect the product in this
    container from excessive heat
    and direct sun.

  • INACTIVE INGREDIENT


    Inactive Ingredients
    helianthus annuus (sunflower)
    seed oil, ricinus communis
    (castor) seed oil, cocos nucifera
    (coconut) oil, polyhydroxystearic
    acid, simmondsia chinensis
    (jojoba) seed oil, euphorbia
    cerifera (candelilla) wax,
    butyrospermum parkii (shea) nut
    extract, squalane, jojoba esters,
    rhus verniciflua peel wax,
    caprylic/capric triglyceride,
    polyglyceryl-3 polyricinoleate,
    isostearic acid, lecithin, ascorbyl
    palmitate, glycerin, averrhoa
    carambola fruit extract,
    tocopherol, octyldodecanol,
    sorbitan oleate, alumina,
    magnesium oxide, flavor.
    may contain (+/-): ci 77491 (iron
    oxides), ci 77492 (iron oxides),
    ci 77499 (iron oxides)

  • PRINCIPAL DISPLAY PANEL

    Tinted Lip Shield

  • INGREDIENTS AND APPEARANCE
    TINTED LIP SHIELD 
    zinc oxide and homosalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79356-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.6 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEANUT (UNII: 84H6HBP32L)  
    HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) (UNII: 96YYQ5TK1K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STAR FRUIT (UNII: G00N2E9394)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SQUALANE (UNII: GW89575KF9)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79356-203-021 in 1 CARTON03/25/2022
    1NDC:79356-203-018.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/25/2022
    Labeler - OneKind.25 (080286020)