CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET REFILL- coretex professional outdoor skin protection wallet refill 
CoreTex Products Inc

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CoreTex Professional Outdoor Skin Protection Wallet Refill
65753-515

Hand Sanitizer
Active Ingredients:

SD Alcohol 40-B 62.5%

Hand Sanitizer
Purpose

Antimicrobial

Hand Sanitizer
Uses:

Hand Sanitizer to help reduce bacteria on the skin.

Hand Sanitizer
Warnings

Flammable. Keep away from heat or flame.

For external use only.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash appears and lasts.

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

Hand Sanitizer
Directions:

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Hand Sanitizer
Inactive Ingredients:

actinidia chinesis (kiwi) extract, aloe barbadenis leaf juice, aminomethyl propanol, brassica oleracea italica (broccoli) extract, cannabis sativa (hemp) seed extract, carbomer citrullus vulgaris (watermelon) fruit extract, euterpe oleracea fruit extract, fragaria vesca (strawberry) fruit extract, glycerin, helianthus annus (sunfloer) seed oil, hippophae rhamnoides (sea buckthorn) fruit extract, lycium barbarum (goji) extract, myrciaria dubia (camu camu) fruit extract, propanediol, propylene glycol, punica granatum extract, rubus idaeus seed extract, tocopherol acetate (vitamin E acetate), vaccinium angustifolium (blueberry) extract, vaccinium macrocarpon (cranberry) fruit extract, vitis vinifera (grape) seed extra, water

Hand Sanitizer
Other Information:

Store below 110 oF (43 o), Read the Safety Data Sheet for this Product. You may obtain an SDS from our website: www.coretexproducts.com or Call: 1-877-684-5774

SunX 30
Active Ingredients:

Avobenzone 3.0%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 5.0%

SunX 30
Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

SunX 30
Uses:

SunX 30
Warnings

For external use only

SunX 30
Do Not Use

  • on damaged or broken skin

When using this product

  • keep out of the eyes
  • rinse with water to remove

Stop use and ask a doctor if

  • rash or irritation develops and lasts

Keep out of reach of children.

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

SunX 30
Directions:

SunX 30
Other Information:

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

SunX 30
Inactive Ingredients:

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, C12-15 alkyl benzoate, carbomer, disodium EDTA, ethylexyiglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan oleate, theobroma cacao (cocoa) seed butter, tocopheryl acetate, water

SunX 30
Questions?

Call: 1-877-684-5774

SunX 50 Lip Balm
Active Ingredients:

Avobenzone…3.0%

Homosalate…3.0%

Octinoxate...7.5%

Octisalate…5.0%

Petrolatum...40.0%

SunX 50 Lip Balm
Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Skin Protectant

SunX 50 Lip Balm
Uses:

Helps protect against sunburn and chapped lips.

SunX 50 Lip Balm
Warnings

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Do not use

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.

SunX 50 Lip Balm
Directions:

SunX 50 Lip Balm
Other information:

protect the product in this container from excessive heat and direct sun.

SunX 50 Lip Balm
Inactive Ingredients:

C12-15 alkyl benzoate, caprylic/capric triglyceride, mineral oil, ozokerite, phenyl trimethicone, tocopherol.

Anti-Itch
Active Ingredients:

Camphor 0.1%

Diphenhydramine hydrochloride 2%

Zinc acetate 1%

Anti-Itch
Purpose

Extrenal analgesic

Antihistamine

Skin protectant

Anti-Itch
Uses:

Anti-Itch
Warnings

For external use only

Do Not Use

  • on chicken pox, blisters or on extensive areas of the skin
  • with any drugs containing diphenhydramine while using this product.

When using this product

  • keep out of eyes.

Stop use and ask a doctor if

  • conditions worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children

If swallowed get medical help or contact Poison Control center right away.

Anti-Itch
Directions:

Anti-Itch
Other Information:

Anti-Itch
Inactive Ingredients:

citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, SD alcohol 40, sodium citrate, water (aqua).

Anti-Itch
Questions?

Call: 1-877-684-5774

Sting X
Active Ingredients:

Benzocaine 6%

Sting X
Purpose

Topical Analgesic

Sting X
Use:

For temporary pain relief from insect bites and stings

Sting X
Warnings

For external use only

Do not use

  • in or near eyes
  • over large areas of the body
  • over raw or blistered areas

Stop use and ask a doctor if

  • conditions worsen or persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed get medical help or contact Poison Control center right away.

Sting X
Directions:

Apply to affected area not more than 3 to 4 times daily, for adults and children 2 years of age or older.

Sting X
Inactive Ingredients:

SD alcohol 40, water (aqua), glycerin, allantoin

Sting X
Other Information:

Made in USA for CoreTex Products, Inc.

Bakersfield, CA 93308

www.CoreTexProducts.com (877)684-5774

Outdoor Professional Kit and Refill Kit Contents

1 ea – Sun X SPF 30 Broad Spectrum Lotion Pouch

1 ea – Sun X SPF 30 Broad Spectrum Multi-Pack Pouch w/Towelette
1 ea – Sun X SPF 30 Lip Balm
2 ea – Bug X 30 Insect Repellent Towelette
2 ea – Ivy X Pre-Contact Barrier Towelette
2 ea – Ivy X Post-Contact Cleanser Towelette
2 ea – Burn X Lite Cooling Gel Pouch
1 ea – Anti-Itch Gel Pouch
1 ea – Sting X Pain Relief Pad
1 ea – Hand Sanitizer Gel Pouch

Professional Outdoor Kit Label

kit openOutdoor kit

Hand Sanitizer
Package Label

65753-200

SunX 30 Label

65753-106

SunX 30 Multipack with Towelette Label

Sunx 30

SunX 50 Lip Balm Label

Lip Balm

Anti-Itch Label

anti itch

Sting X Label

bug x

Burn X Label
65753

Burn X

IVY X Cleanser Label

IVY X Cleanser

IVY X Pre Label

IVY X Pre

CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET REFILL 
coretex professional outdoor skin protection wallet refill kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-515
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65753-515-361 in 1 KIT; Type 0: Not a Combination Product02/24/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 44 mL
Part 21 POUCH 7 g
Part 314809258 APPLICATOR 65753105 mL
Part 41 POUCH 1 mL
Part 51 POUCH 1.1 mL
Part 61 POUCH 3.5 mL
Part 1 of 6
CORETEX SUN X SPF 30 NEW 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Item Code (Source)NDC:65753-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
PROPYLENE GLYCOL PROPYL ETHER (UNII: 92KA3PYX0S)  
Product Characteristics
Colorwhite (Thick White Lotion) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65753-110-3744 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/01/2023
Part 2 of 6
CORETEX SUN X SPF 30 MULTIPACK NEW 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Item Code (Source)NDC:65753-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
PROPYLENE GLYCOL PROPYL ETHER (UNII: 92KA3PYX0S)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65753-109-397 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/01/2023
Part 3 of 6
SUN X SPF 50 BROAD SPECTRUM SUNSCREEN LIP BALM 
avobenzone, homosalate, octinoxate, octisalate, petrolatum lipstick
Product Information
Item Code (Source)NDC:65753-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM40 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MINERAL OIL (UNII: T5L8T28FGP)  
WHITE WAX (UNII: 7G1J5DA97F)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65753-108-394.44 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/24/2023
Part 4 of 6
CORETEX ANTI-ITCH GEL 
camphor, diphenhydramine, zinc acetate gel
Product Information
Item Code (Source)NDC:65753-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.1 g  in 100 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 g  in 100 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL 1-ALLYL ETHER (UNII: QRB8092KPK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65753-400-391 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/01/2023
Part 5 of 6
STINGX 
benzocaine swab
Product Information
Item Code (Source)NDC:65753-350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALLANTOIN (UNII: 344S277G0Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.1 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/25/2019
Part 6 of 6
CORETEX ANTIBACTERIAL HAND SANITIZER 
sd alcohol liquid
Product Information
Item Code (Source)NDC:65753-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13.5 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00411/25/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/24/2023
Labeler - CoreTex Products Inc (061944620)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises017701475manufacture(65753-400, 65753-350)
Establishment
NameAddressID/FEIBusiness Operations
CoreTex Products Inc061944620pack(65753-515, 65753-200, 65753-108, 65753-110, 65753-109, 65753-350, 65753-400)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source080354456manufacture(65753-109, 65753-110)
Establishment
NameAddressID/FEIBusiness Operations
Raining Rose083819404manufacture(65753-108)
Establishment
NameAddressID/FEIBusiness Operations
HealthSpecialty794053863manufacture(65753-200)

Revised: 11/2023
Document Id: 0958059a-66de-da55-e063-6294a90ad449
Set id: 095855ef-85f5-dacd-e063-6294a90a597c
Version: 1
Effective Time: 20231104
 
CoreTex Products Inc