SUNSCREEN WITH UV PEARLS BROAD SPECTRM SPF 20 (ZINC OXIDE, OCTINOXATE) LOTION [ISOMERS LABORATORIES INC]

SUNSCREEN WITH UV PEARLS BROAD SPECTRM SPF 20 (ZINC OXIDE, OCTINOXATE) LOTION [ISOMERS LABORATORIES INC]
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NDC 64990-885-01
Set ID 4ef6146c-4f3d-498f-8b73-f605131f6054
Category HUMAN OTC DRUG LABEL
Packager Isomers Laboratories Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

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    Active Ingredients:

    Zinc Oxide                           8.0%

    Octyl Methoxycinnamate      7.5%

  • PURPOSE

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    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    • helps prevent sunburn
    • if used as directed with other sun protection measures (See Direction ),decreases the risk of skin cancer and early skin aging caused by the sun.
  • WARNINGS

    • For external use only
    • When using this product, keep out of eyes.Rinse with watewr to remove.

    Do Not Use on damaged or broken skin

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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    • Keep out of reach of children
    • If product is swallowed get medical help or contact the Poison Control Center right away.

  • INACTIVE INGREDIENT

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    Inactive Ingredients:

    Purified Water, Cetearyl Alcohol, Phenyl Trimethicone, Caprylic/Capric Triglyceride, Propylen Glycol, Ceteareth-20, Polyhydroxystearic Acid, Mineral Oil, Panthenol, Silica, PVP, Chlorphenesin, Tocopheryl Acetate, Aloe Barbadensis Leaf extract, Polysorbate 60, BHT, Phenoxyethanol, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben.

  • DOSAGE & ADMINISTRATION

    • Apply Liberally 15 minutes before sun exposure.
    • reapply at least every two hours
    • use a water -resistant sunscreen if swimming or sweating
    • children under 6 months of age: 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, regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures.
    • Limit time in the sun especially from 10 a.m. to 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses.

  • PRINCIPAL DISPLAY PANEL

    MM10 image of product label

    image of product label

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN WITH UV PEARLS BROAD SPECTRM SPF 20 
    zinc oxide, octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64990-885
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc Oxide80 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Panthenol (UNII: WV9CM0O67Z)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64990-885-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product09/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/31/2003
    Labeler - Isomers Laboratories Inc (253306799)
    Registrant - Isomers Laboratories Inc (253306799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Isomers laboratories Inc253306799manufacture(64990-885)

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