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

OBAGI SUN SHIELD TINT WARM SUNSCREEN BROAD SPECTRUM SPF 50 (HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OMP, INC.]
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NDC 62032-160-10, 62032-160-99
Set ID b1aacb4d-7ede-4aae-8d6a-afff2a057e46
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

    Homosalate 10%

    Octinoxate 7.5%

    Titanium dioxide 3.19%

    Sunscreen

    Sunscreen

    Sunscreen

    Zinc oxide 5%

    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
    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
  • Other information

    store at controlled room temperature: 15°C–25°C (59°F–77°F)
    protect this product from excessive heat and direct sun
  • Inactive ingredients

    water, butyloctyl salicylate, caprylic/capric triglyceride, caprylyl methicone, polyglyceryl-10

    pentastearate, glyceryl stearate, PEG-100 stearate, butylene glycol, pentylene glycol, behenyl alcohol, iron oxides, PEG-40 stearate, dimethicone, physalis angulata extract, phenoxyethanol, algae extract, glycerin, mica, sodium stearoyl lactylate, polyhydroxystearic acid, mannitol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, citric acid, squalane, alumina, stearic acid, xanthan gum, diatomaceous earth, sodium polyacrylate, disodium EDTA, ethylhexylglycerin, synthetic fluorphlogopite, polysorbate 60, zinc sulfate, chlorphenesin, tetrahexyldecyl ascorbate, tin oxide, tocopherol

  • Questions or comments?

    1.800.636.7546

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

  • Principal Display Panel

    OBAGI®

    MEDICAL

    Sun Shield

    TINT

    Broad

    Spectrum

    SPF 50

    Sunscreen

    Lotion

    [sun icon]

    WARM

    Infrared

    Defense

    Non-comedogenic

    Dermatologist tested

    Net wt. 3 oz. (85 g)

    Obagi Sun Shield TINT Warm Sunscreen Broad Spectrum SPF 50 Carton
  • INGREDIENTS AND APPEARANCE
    OBAGI  SUN SHIELD TINT WARM SUNSCREEN BROAD SPECTRUM SPF 50
    homosalate, octinoxate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8.5 g  in 85 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.375 g  in 85 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.711 g  in 85 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.25 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    12-OXOOCTADECANOIC ACID (UNII: 31GL7GRO8F)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICA (UNII: V8A1AW0880)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    MANNITOL (UNII: 3OWL53L36A)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SQUALANE (UNII: GW89575KF9)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-160-101 in 1 CARTON01/01/2016
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:62032-160-9925 in 1 TRAY01/01/2016
    25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2016
    Labeler - OMP, INC. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135MANUFACTURE(62032-160)

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