Label: BARE SKIN MINERAL COVER SPF27- octinoxate and octisalate powder powder

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 29, 2015

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  • Active Ingredients:

    Octinoxate 3.8 %
    Octisalate 2.5 %

  • Purpose

    Sunscreen

    Sunscreen

  • Uses:

    Helps prevent sunburn.

  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply generously and evenly 15 minutes before sun exposure.
    Children under 6 months of age: Ask a doctor.
    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    Reapply at least every 2 hours.
    Use a water-resistant sunscreen if swimming or sweating.

    Apply an adequate amount on face in a light patting motion by using puff.

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sun.

    May stain or damage some fabrics or surfaces.

  • Inactive Ingredients:

    TALC, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, TITANIUM DIOXIDE, ZINC OXIDE, SILICA, PHENYL TRIMETHICONE, 1,2-HEXANEDIOL, AMINOPROPYL DIMETHICONE, MICA, POLYMETHYLSILSESQUIOXANE, METHICONE, ALUMINA, GLYCERYL CAPRYLATE, RUBUS CHAMAEMORUS SEED EXTRACT,VOLCANIC ASH, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER WATER, WATER, BUTYLENE GLYCOL, CHENOPODIUM QUINOA SEED EXTRACT, FRAGRANCE, IRON OXIDES (CI 77492, CI 77491, CI77499)

  • QUESTIONS

    Questions or comments? Call 1-866-638-8417

  • Distributed by:

    THEFACESHOP NORTH AMERICA, INC.

    Santa Fe Springs, CA 90670

  • PRINCIPAL DISPLAY PANEL

    BARE SKIN
    MINERAL COVER SUNSCREEN POWDER
    N203 NATURAL BEIGE SPF27 PA++
    Mineral cover powder keeps skin looking flawless for many hours.
    Provides a flawless, smooth finish that keeps makeup looking fresh for many hours.
    Creates a blurring effect that smoothes out the curves and pores of the skin.
    Contains Perfect Seed to keep skin fresh and clean by taking care of dead skin cells and sebum.

    Label

  • INGREDIENTS AND APPEARANCE
    BARE SKIN  MINERAL COVER SPF27
    octinoxate and octisalate powder powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-475
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.57 g  in 15 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.38 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-475-371 in 1 CARTON10/01/2015
    115 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2015
    Labeler - THEFACESHOP CO., LTD. (688329416)
    Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP CO., LTD.688329416label(51523-475)