VANILLA MINT LIP SPF 30 BALM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) STICK [RAINING ROSE, INC.]

VANILLA MINT LIP SPF 30 BALM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) STICK [RAINING ROSE, INC.]
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NDC 65692-0201-1
Set ID 76905526-dc55-46f0-b4a7-c910cf1297c6
Category HUMAN OTC DRUG LABEL
Packager Raining Rose, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • PEEL HERE FOR DRUG FACTSBROAD SPECTRUN SPF 30 SunscreenVanilla Mint Lip Balm - 0201

    Active Ingredients:

    Avobenzone 3.0%
    Homosalate 7.5%
    Octisalate 5.0%
    Octocrylene 2.5%
    Oxybenzone 6.0%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    For External Use Only 

  • Do not use

    on damaged or broken skin

  • Stop use and as a doctor if

    • rash occurs
  • When using this product

    • Keep out of eyes.

    Rinse well with water to remove.

  • Keep out of reach of children.

    If swalowed, get medical help or call a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • 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 protection measures including:

    • limit time in the sun, s\especially from 10a.m. - 2p.m.
    • wear long slessved shirts, pants, hat, and sunglasses.
  • Inactive Ingredients:

    Sunflower oil*, beeswax, extra virgin olive oil*, flavor hemp seed oil*, rosemary extract, vitamin E, Aloe vera.

    *Certified Organic

  • Other Information

    Protect this product from excessive heart and direct sun.

  • Vanilla Mint Lip Balm SPF 30 product label

    Dist. by: Raining Rose, Inc. Cedar Rapids, IA 52403

    RR Vanilla Mint

  • INGREDIENTS AND APPEARANCE
    VANILLA MINT LIP  SPF 30 BALM
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.12 g  in 4.25 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.32 g  in 4.25 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.21 g  in 4.25 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.10 g  in 4.25 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.25 g  in 4.25 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    ROSEMARY (UNII: IJ67X351P9)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0201-14.25 g in 1 CONTAINER; Type 0: Not a Combination Product12/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/19/2016
    Labeler - Raining Rose, Inc. (083819404)
    Registrant - Raining Rose, Inc. (083819404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose, Inc.083819404manufacture(65692-0201) , label(65692-0201) , relabel(65692-0201) , repack(65692-0201)

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