OBAGI SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OMP, INC.]

OBAGI SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OMP, INC.]
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NDC 62032-810-03
Set ID eebe6ed9-b55a-4e35-8dff-77a0e3108fb2
Category HUMAN OTC DRUG LABEL
Packager OMP, INC.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose

    Titanium dioxide 4.9%

    Sunscreen

    Zinc oxide 4.7%

    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
    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

    water, butyloctyl salicylate, cetyl dimethicone, dimethicone, styrene/acrylates copolymer, trimethylsiloxysilicate, dimethicone PEG-8 laurate, isohexadecane, butylene glycol, polysorbate 60, trisiloxane, arachidyl alcohol, polyhydroxystearic acid, hydrated silica, ceramide 3, ceramide 6-II, ceramide 1, niacinamide, cholesterol, phytosphingosine, PEG-100 stearate, glyceryl stearate, ascorbic acid, avena sativa (oat) kernel extract, arachidyl glucoside, beeswax, behenyl alcohol, benzyl alcohol, stearic acid, bisabolol, dipotassium glycyrrhizate, ethylhexylglycerin, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, pantothenic acid/yeast polypeptide, PEG-8, xanthan gum, polyaminopropyl biguanide, polymethyl methacrylate, alumina, potassium sorbate, retinyl palmitate, sodium lauroyl lactylate, carbomer, tocopheryl acetate, BHT, disodium EDTA, methicone, methylisothiazolinone, triethoxycaprylylsilane

  • 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

    OBAGI®

    MEDICAL

    Sun Shield

    MINERAL

    BROAD SPECTRUM SPF 50

    [sun icon]

    Sunscreen

    Lotion

    Water resistant

    (40 minutes)

    Non-comedogenic

    Net wt. 3 oz. (85 g)

    Obagi Sun Shield Mineral Broad Spectrum SPF 50 3 oz Carton
  • INGREDIENTS AND APPEARANCE
    OBAGI  SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide4.165 g  in 85 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide3.995 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    OAT (UNII: Z6J799EAJK)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-810-031 in 1 CARTON
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/01/2015
    Labeler - OMP, INC. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135MANUFACTURE(62032-810)

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