PYRATINE XR CREME WITH SUNSCREEN BROAD SPECTRUM SPF30 (ZINC OXIDE) CREAM [ALLURE LABS INC]

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PYRATINE XR CREME WITH SUNSCREEN BROAD SPECTRUM SPF30 (ZINC OXIDE) CREAM [ALLURE LABS INC]
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NDC 62742-4145-1, 62742-4145-2
Set ID fc316b19-c1cf-4b5b-9f22-9672b7d0cbff
Category HUMAN OTC DRUG LABEL
Packager Allure Labs Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active Ingredient: Zinc oxide - 18.6%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • Help prevent sunburn. Higher SPF gives more sunburn protection. Provide high protection against 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: For external use only. Do not use on damaged or broken skin.

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash or irritation developes and lasts.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions:

    • For sunscreen use. 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 protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.
  • OTHER SAFETY INFORMATION

    protect this product from excessive heat and direct sun.

  • QUESTIONS

    Call toll free 1-888-467-9728

  • STORAGE AND HANDLING

    Store at controlled room temperature 59 F - 89 F (15 C - 30 C).

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water (Aqua), Cyclopentasiloxane, Butylene glycol, glycerin, Propylene Glycol, Caprylic/Capric triglyceride, Glycerin Stearate, PEG-100 Stearate, Polyglyceryl-3 Polymethylsiloxyeethyl Dimethicon, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, Hexylene glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan gum, Furfuryl Tetrahydropyranyladinine, tocopherol Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract and Micrococcus Lysate.

  • PRINCIPAL DISPLAY PANEL

    Developed, Distributed and Marketed by:

    Pyratine LLC

    2950 Main Street

    Morro Bay, CA 93442

    1-888-467-9728

    www.pyratine.com

    Image Pyratine XR

    Image Pyratine XR

  • INGREDIENTS AND APPEARANCE
    PYRATINE XR CREME WITH SUNSCREEN BROAD SPECTRUM SPF30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4145
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION186 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYESTER-7 (UNII: 0841698D2F)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)  
    TEPRENONE (UNII: S8S8451A4O)  
    DATE (UNII: H3O7QI5HY7)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4145-21 in 1 CARTON12/07/2017
    1NDC:62742-4145-156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/07/2017
    Labeler - Allure Labs Inc (926831603)
    Registrant - Allure Labs Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs Inc926831603manufacture(62742-4145)
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