SUNSCREEN (OCTOCRYLENE ,HOMOSALATE,AVOBENZONE,OCTISALATE) LOTION [YUYAO JESSIE COMMODITY CO.,LTD.]

SUNSCREEN (OCTOCRYLENE ,HOMOSALATE,AVOBENZONE,OCTISALATE) LOTION [YUYAO JESSIE COMMODITY CO.,LTD.]
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NDC 51414-907-01, 51414-907-02, 51414-907-03, 51414-907-04, 51414-907-05, 51414-907-06, 51414-907-07, 51414-907-08, 51414-907-09, 51414-907-10, 51414-907-11, 51414-907-12, 51414-907-13, 51414-907-14, 51414-907-15, 51414-907-16, 51414-907-17, 51414-907-18, 51414-907-19, 51414-907-20
Set ID 77220c16-6bd6-8780-e053-2991aa0ad2b3
Category HUMAN OTC DRUG LABEL
Packager Yuyao Jessie Commodity Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredient


    OCTOCRYLENE 10%
    HOMOSALATE10%
    OCTISALATE 5 %
    AVOBENZONE 3%

    Purpose

    Sunscreen

  • Use

    hellps prevent sunburn.

    Higher SPF gives more sunburn protection
    For skin highly sensitive to sunburn

  • WARNINGS

    For External use only.

    Do not us 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 product is swallowed,get medical help or contact a Poison Control Center right away.

  • Directions

    •Apply generously & evenly 15 minutes before sun exposure.
    •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,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.
    •Reapply at least every 2 hours
    •use a water resistant sunscreen if swimming orsweating.

  • Inactive ingredients

    Water,Glycerin,Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol,Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer,Bisabolol,Carbomer,Fragrance, Triethanolamine,Disodium EDTA

  • lebel

    1234

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    octocrylene ,homosalate,avobenzone,octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-907
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIETHANOLAMINE ISOSTEARATE (UNII: T8OTU5ECY5)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    WATER (UNII: 059QF0KO0R)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BEHENETH-25 METHACRYLATE (UNII: 108R05PWG6)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51414-907-015 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    2NDC:51414-907-028 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    3NDC:51414-907-0310 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    4NDC:51414-907-0415 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    5NDC:51414-907-0520 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    6NDC:51414-907-0630 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    7NDC:51414-907-0740 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    8NDC:51414-907-0850 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    9NDC:51414-907-0960 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    10NDC:51414-907-1080 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    11NDC:51414-907-1190 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    12NDC:51414-907-12100 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    13NDC:51414-907-13120 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    14NDC:51414-907-14150 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    15NDC:51414-907-15200 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    16NDC:51414-907-16240 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    17NDC:51414-907-17300 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    18NDC:51414-907-18360 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    19NDC:51414-907-19400 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    20NDC:51414-907-20500 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/12/2012
    Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Jessie Commodity Co.,Ltd.529892305manufacture(51414-907)

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