SPEARMINT LIP BALM BROAD SPECTRUM VERTRA- avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick 
Eai-Jr286, 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.

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Spearmint Lip Balm Broad Spectrum SPF 30

Active Ingredients               Purpose

Avobenzone   3.0%            Sunscreen

Homosalate   7.5%            Sunscreen
Octisalate     5.0%             Sunscreen

Octocrylene   2.5%            Sunscreen

Oxybenzone  6.0%            Sunscreen

Uses  Helps Prevent Sunburn

Keep out of reach of children. If Swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask a doctor if

  • rash occurs

For External use

Do not use on damaged or broken skin

When using this product

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

  • apply liberally 15 minutes before sun exposure
  • Use a water resisntant if swimmig 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 Borad 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

Sunflower oil, Beeswax, Extra Virgin Olive Oil, Flavor, Hemp seed Oil, Rosemary Extract, Vitamin E, Aloe Vera Oil

Vertraa Elemenetal Resistance

Lip Balm Broad Spectrum Sunscreen SPF 30+

Spearmint

Net Wt. .15 oz.

Spearmint Label

SPEARMINT LIP BALM BROAD SPECTRUM  VERTRA
avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71014-007-014 g in 1 CYLINDER; Type 0: Not a Combination Product11/22/201612/26/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/22/201612/26/2018
Labeler - Eai-Jr286, Inc. (827896718)
Registrant - Eai-Jr286, Inc. (827896718)
Establishment
NameAddressID/FEIBusiness Operations
Raining Rose, Inc.083819404manufacture(71014-007)

Revised: 1/2019
Document Id: 2b28939f-3e9f-4776-ae43-cc9757a641a5
Set id: 8f70be52-b725-45e7-939d-9efdd694582b
Version: 3
Effective Time: 20190122
 
Eai-Jr286, Inc.