WHITE GIRL SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [WHITE GIRL, LLC]

WHITE GIRL SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [WHITE GIRL, LLC]
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NDC 70641-111-01
Set ID 2f266c8f-7b7f-4ba5-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager White Girl, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Octinoxate 7%

    Homosalate 3%

    Octocrylene 6%

    Avobenzone 2.5%

    White Girl 30 SPF Sunscreen Active Ingredients

  • Drug Facts

    Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions)
    • decreases the risk of skin cancer and early skin aging caused by sun

    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 liberally 15 minutes before sun exposure
    • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increasess your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum spf of 30 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m-2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

    Other Information

    protect this product from excessive heat and direct sun

    White Girl Sunscreen Package Label Display

  • White Girl Sunscreen 30 SPF

    White Girl Sunscreen 30 SPF

    www.whitegirlsunscreen.com

  • INGREDIENTS AND APPEARANCE
    WHITE GIRL SUNSCREEN 
    avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70641-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARETH-21 (UNII: 53J3F32P58) 1.5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70641-111-01100 g in 1 POUCH; Type 0: Not a Combination Product06/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/06/2016
    Labeler - White Girl, LLC (080196333)
    Registrant - Bath Concept Cosmetics (Dongguan) Co., Ltd. (529623933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bath Concept Cosmetics (Dongguan) Co., Ltd.529623933manufacture(70641-111)

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