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 
Raining Rose, Inc.

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.

----------

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

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)

Revised: 12/2017
Document Id: 615914d2-bd21-4048-e053-2991aa0a41d8
Set id: ade670ee-de2f-4b9a-8b4e-7fdcb73af798
Version: 3
Effective Time: 20171227
 
Raining Rose, Inc.