Label: SPEARMINT SPF 15 LIP- avobenzone, octinoxate, octisalate, octocrylene stick
BEESWAX SPF 15 LIP- avobenzone, octinoxate, octisalate, octocrylene stick
POMEGRANATE SPF 15 LIP- avobenzone, octinoxate, octisalate, octocrylene stick
TROPICAL SPF 15 LIP- avobenzone, octinoxate, octisalate, octocrylene stick
VANILLA SPF 15 LIP- avobenzone, octinoxate, octisalate, octocrylene stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 December 27, 2017

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  • PEEL HERE FOR DRUG FACTS Broad Spectrum SPF 15 Sunscreen Spearmint Lip Balm, Beeswax Lip Balm, Pomegranate Lip Balm, Tropical Lip Balm, Vanilla Lip Balm Drug Facts

    Active Ingredients:
    Avobenzone 2.0%
    Octinoxate 6.5%
    Octsalate 5.0%
    Octocrylene 1.5%


  • Purpose

    Sunscreen

  • Keep out of reach of children.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    Helps prevent sunburn

  • Warnings

    For external use only

  • Do not use

    on damaged or broken skin

  • Stop use and ask a doctor

    if rash occurs

  • When using this product

    keep out of eyes. Rinse well with water to remove.

  • 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 sun protection measures including limit time in the sun, especially from 10a.m. - 2p.m.  wear long sleeved shirts, pants, hats, and sunglasses.

  • Inactive Ingredients

    Sunflower oil*, beeswax, extra virgin olive oil*, hemp seed oil*, rosemary extract, vitamin E, aloe vera
    *Certified Organic

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Product Label Spearmint Lip Balm Beeswax Lip Balm Pomegranate Lip Balm Tropical Lip Balm Vanilla Lip Balm

    Dist. by: Raining Rose, Inc. Cedar Rapids IA 52403    L000000

    PEEL HERE FOR DRUG FACTS
    Broad Spectrum SPF Sunscreen

    NetWt. .15 oz

    Spearmint Lip Balm
    Beeswax Lip Balm
    Pomegranate Lip Balm
    Tropical Lip Balm
    Vanilla Lip Balm


    RR Spearmint LB Label


    RR Beeswax LB Label


    RR Pomegranate LB Label


    RR Tropical LB Label

    RR Vanilla LB Label

  • INGREDIENTS AND APPEARANCE
    SPEARMINT SPF 15 LIP  
    avobenzone, octinoxate, octisalate, octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.09 g  in 4.25 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.28 g  in 4.25 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.21 g  in 4.25 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.06 g  in 4.25 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    ROSEMARY (UNII: IJ67X351P9)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINT (SPEARMINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0301-14.25 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2012
    BEESWAX SPF 15 LIP 
    avobenzone, octinoxate, octisalate, octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.09 g  in 4.25 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.28 g  in 4.25 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.21 g  in 4.25 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.06 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:65692-0302-14.25 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2012
    POMEGRANATE SPF 15 LIP 
    avobenzone, octinoxate, octisalate, octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.09 g  in 4.25 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.28 g  in 4.25 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.21 g  in 4.25 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.06 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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPOMEGRANATE (POMEGRANATE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0303-14.25 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2012
    TROPICAL SPF 15 LIP 
    avobenzone, octinoxate, octisalate, octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.09 g  in 4.25 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.28 g  in 4.25 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.21 g  in 4.25 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.06 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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorTROPICAL FRUIT PUNCH (TROPICAL) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0304-14.25 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2012
    VANILLA SPF 15 LIP 
    avobenzone, octinoxate, octisalate, octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0305
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.09 g  in 4.25 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.28 g  in 4.25 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.21 g  in 4.25 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.06 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:65692-0305-14.25 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2012
    Labeler - Raining Rose, Inc. (083819404)
    Registrant - Raining Rose, Inc. (083819404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose, Inc.083819404manufacture(65692-0301, 65692-0305, 65692-0302, 65692-0303, 65692-0304)
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