OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]

OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]
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NDC 76151-105-11, 76151-105-52
Set ID ec322ae5-ab03-4c7b-9c6d-0bda3327c72a
Category HUMAN OTC DRUG LABEL
Packager Boscia LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients       Purpose
    Octinoxate 5%           Sunscreen
    Avobenzone 3%         Sunscreen

  • PURPOSE

    Use Helps prevent sunburn.

  • WARNINGS

    Warnings For external use only.

  • WHEN USING

    Avoid direct contact with eyes. If contact occurs, rinse gently with water.

  • STOP USE

    Discontinue use and consult a physician immediately if any adverse reaction occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions  Apply small amount in AM to cleansed and toned face as last skincare step.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Butylene Glycol, Silica, Glycerin, Polyglyceryl-10 Stearate, Pentylene Glycol, Simmondsia Chinensis (Jojoba) Leaf Extract, Epilobium Angustifolium Flower/leaf/stem Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Algae Extract, Hydrolyzed Yeast Extract, Arctium Lappa Root Extract, Phellodendron Amurense Bark Extract, Hydrogenated Rapeseed Alcohol, Hydroxyethylcellulose, Sclerotium Gum, Aluminum Hydroxide, Potassium Phosphate, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Zinc Oxide, Titanium Dioxide.

  • DESCRIPTION

    Preservative-free.  Dermatologist tested.  Non-comedogenic.  Alcohol-free, pH balanced, 100% natural fragrance and color, no animals testing and no animal ingredients.    An oil-free moisturizer that hydrates the skin, minimizes pores and providers broad spectrum SPF 15.  Polysaccharide provides essential moisture, silica powder controls excessive oil while wine Yeast and Marine Complex help protect against external elements.  www.boscia.net  B105-11  Distributed by  boscia LLC. Irvine, CA 92614  Made in Japan   U8-2

  • PRINCIPAL DISPLAY PANEL

    boscia  Oil-free  Daily Hydration  SPF 15  For normal to oily skin  Preservative-free  1.4 fl oz/40 ml

  • PRINCIPAL DISPLAY PANEL

    www.boscia.net  B105-11  Distributed by  boscia LLC. Irvine, CA 92614  Made in Japan   U8-2

  • PRINCIPAL DISPLAY PANEL

    Boscia 1

  • PRINCIPAL DISPLAY PANEL

    Boscia 2

  • INGREDIENTS AND APPEARANCE
    OIL-FREE DAILY HYDRATION SPF 15 
    octinoxate, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76151-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    ROSEMARY (UNII: IJ67X351P9)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    POTASSIUM PHOSPHATE (UNII: B7862WZ632)  
    CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76151-105-5215 mL in 1 TUBE; Type 0: Not a Combination Product12/19/2017
    2NDC:76151-105-1140 mL in 1 TUBE; Type 0: Not a Combination Product12/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/16/2011
    Labeler - Boscia LLC (967960951)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080987545manufacture(76151-105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab Korea Co., Ltd.690104005manufacture(76151-105)

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