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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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CoreTex Professional Outdoor Skin Protection Wallet
and Refill Wallet

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 1.0%

Homosalate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 6.0%

SunX 30
Purpose

Sunscreen

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 occurs

SunX 30
Keep out of reach of children

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

SunX 30
Directions

SunX 30
Other Information

SunX 30
Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita extract, dimethicone, dimethyl capramide, ethylparaben, fragrance, glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale leaf extract, tetrasodium EDTA, triethanolamine, tocopherol, tocopherol acetate, water

SunX 30
Questions?

Call: 1-877-684-5774

SunX 30 Lip Balm
Active Ingredients

Avobenzone…3.0%

Homosalate…7.5%

Octisalate…5.0%

Octocrylene…2.5%

Oxybenzone…6.0%

SunX 30 Lip Balm
Purpose

Sunscreen

SunX 30 Lip Balm
Uses

Helps prevent sunburn.

SunX 30 Lip Balm
Warnings

For external use only.

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.

SunX 30 Lip Balm
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 30 Lip Balm
Directions

SunX 30 Lip Balm
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:

SunX 30 Lip Balm
Inactive Ingredients

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

SunX 30Lip Balm
Other information

Protect this productfrom excessive heat and direct sun.

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.

Anti-Itch
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

Sting X
Stop use and ask a doctor if

Sting X
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

Professional Outdoor Kit

Professional Outdoorkit Refill

Outdoor Kit Refill

Hand Sanitizer
Package Label

hand sanitizer label

SunX 30 Label

SunX 30

SunX 30 Multipack with Towelette Label

SunX 30 towelette

SunX 30 Lip Balm Label

Lip Balm

Anti-Itch Label

anti-itch label

Sting X Label

Sting X label

CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET 
coretex professional outdoor skin protection wallet kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-504
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65753-504-361 in 1 KIT; Type 0: Not a Combination Product11/27/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 44 mL
Part 21 POUCH 7 g
Part 31480926 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 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Item Code (Source)NDC:65753-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
CHAMOMILE (UNII: FGL3685T2X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PEG-100 STEARATE (UNII: YD01N1999R)  
NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
COMFREY LEAF (UNII: DG4F8T839X)  
Product Characteristics
Colorwhite (Thick White Lotion) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65753-100-3744 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/25/2013
Part 2 of 6
SUN X MULTI-PACK SPF 30 THICK 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Item Code (Source)NDC:65753-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PEG-100 STEARATE (UNII: YD01N1999R)  
NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
COMFREY LEAF (UNII: DG4F8T839X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
CHAMOMILE (UNII: FGL3685T2X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
17 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2017
Part 3 of 6
SUN XSPF 30 BROAD SPECTRUM SUNSCREEN LIP BALM 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lipstick
Product Information
Item Code (Source)NDC:65753-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 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
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
COCOA BUTTER (UNII: 512OYT1CRR)  
COCONUT OIL (UNII: Q9L0O73W7L)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
144.4 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
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
11 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/25/2019
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 not finalpart34811/25/2019
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
EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
HIPPOPHAE RHAMNOIDES FRUIT JUICE (UNII: UC3P08EB3Y)  
PROPYLENE GLYCOL 1-BUTYRATE (UNII: PUV901J64H)  
VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW)  
ACTINIDIA CHINENSIS WHOLE (UNII: 8HTD3WU8LH)  
BRASSICA OLERACEA VAR. ITALICA WHOLE (UNII: DW4954EP53)  
CANNABIS SATIVA SEED (UNII: QE567Z26NG)  
PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)  
FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6)  
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
GLYCERIN (UNII: PDC6A3C0OX)  
HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)  
VACCINIUM MACROCARPON WHOLE (UNII: D11KO7O2DX)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR)  
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 not finalpart333E11/25/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/27/2019
Labeler - CoreTex Products Inc (061944620)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises017701475manufacture(65753-350, 65753-400)
Establishment
NameAddressID/FEIBusiness Operations
CoreTex Products Inc061944620pack(65753-504, 65753-200, 65753-105, 65753-102, 65753-100, 65753-350, 65753-400)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source080354456manufacture(65753-100, 65753-102)
Establishment
NameAddressID/FEIBusiness Operations
Raining Rose083819404manufacture(65753-105)
Establishment
NameAddressID/FEIBusiness Operations
HealthSpecialty794053863manufacture(65753-200)

Revised: 11/2022
Document Id: ee065ea3-580a-2105-e053-2a95a90a700f
Set id: 9b6ff9ca-8d7a-ea1b-e053-2a95a90a514f
Version: 2
Effective Time: 20221121
 
CoreTex Products Inc