Label: SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN- octinoxate and 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 August 5, 2016

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  • Drug Facts

  • Active ingredients

    Octinoxate 7.5%, Zinc Oxide 10.5%

  • 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

    Stop use and ask a doctor if rash occurs

    When using this product keep out of 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
    ▪
    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

    1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum

  • Other information

    ▪
    store at controlled room temperature: 15°C–25°C (59°F–77°F)
    ▪
    protect this product from excessive heat and direct sun
  • Questions or comments?

    1.800.636.7546

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

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Label

    OBAGI®
    MEDICAL

    Sun Shield

    MATTE

    Broad
    Spectrum
    SPF 50

    Sunscreen
    Lotion

    Non-Comedogenic

    Dermatologist Tested

    Net wt. 3 OZ (85 g)

    Sun Shield Broad Spectrum SPF 50 MATTE Sunscreen Lotion - 85g
  • INGREDIENTS AND APPEARANCE
    SUN SHIELD BROAD SPECTRUM SPF 50 MATTE  SUNSCREEN
    octinoxate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE105 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-125-901 in 1 CARTON02/21/2013
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:62032-125-0515 g in 1 TUBE; Type 0: Not a Combination Product02/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/21/2013
    Labeler - OMP, Inc. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei INC.105803274MANUFACTURE(62032-125) , LABEL(62032-125) , PACK(62032-125)
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