Sun X Lip Balm

Sun X Lip Balm

Drug Labeling and Warnings

Drug Details

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SUN XSPF 30 BROAD SPECTRUM SUNSCREEN LIP BALM- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lipstick 
CoreTex Products, 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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Sun X Lip Balm

Active Ingredients

Avobenzone…3.0%

Homosalate…7.5%

Octisalate…5.0%

Octocrylene…2.5%

Oxybenzone…6.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

  • 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 to remove.

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.

Directions

  • apply liberally 15 minutes before sun exposure
  • Use 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:

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

Inactive Ingredients

Beeswax, castor oil, cocoa butter, coconut oil, shea utter

Other Information

Protect this productfrom excessive heat and direct sun.

Coretex lip balm

SUN XSPF 30 BROAD SPECTRUM SUNSCREEN LIP BALM 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65753-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
WHITE WAX (UNII: 7G1J5DA97F)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCOA BUTTER (UNII: 512OYT1CRR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65753-105-3624 in 1 CONTAINER01/01/2017
14.44 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC: 65753-105-2350 in 1 CONTAINER01/01/2017
24.44 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3NDC: 65753-105-3872 in 1 CONTAINER01/01/2017
34.44 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2017
Labeler - CoreTex Products, INC (061944620)
Establishment
NameAddressID/FEIBusiness Operations
CoreTex Products, INC061944620label(65753-105)
Establishment
NameAddressID/FEIBusiness Operations
Westwood Laboratories069926483manufacture(65753-105)

Revised: 6/2019
 
CoreTex Products, INC


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